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Tangji Gastric Bypass Stent Study for Obesity

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Gastric Bypass Stent System
Dietary Intervention
Sponsored by
Hangzhou Tangji Medical Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aged 18-60 years, both male and female; Obese patients with BMI ≥ 30 kg/m2, who are willing to be treated with Gastric Bypass Stent System or dietary intervention; Patients with ASA I~II grade; The patient understands the onjective of the trial and is volunteered to participate in the trial and has signed the Informed Consent Form (ICF). Exclusion Criteria: Have a weight loss of more than 4.5 kg in the past three months, or take weight-loss drugs in the past month; Patients who used non-steroidal anti-inflammatory drugs (NSAIDs) and corticosteroids in the past month; Patients diagnosed with type 1 diabetes; Patients with the function of islet β cell basically lost, C-peptide ≤ 1/2 of the normal low limit or low and flat C-peptide release curve under glucose load; Patients with iron deficiency or iron deficiency anemia; Patients with coagulation dysfunction who used aspirin and other anticoagulants in the past month; Patients with severe liver and kidney dysfunction, and the serum creatinine concentration of greater than 180 μmol/L; Patients with Class III heart function of NYHA or higher, or pulmonary dysfunction; Patients who have undergone ERCP procedure, or have a history of cholecystitis or liver abscess; Patients with duodenal ulcer, gastric ulcer or previous and existing pancreatitis; Patients with gallstones (diameter ≥ 20 mm) with clinical symptoms; Patients with thyroid dysfunction; Patients with hemorrhage or potential hemorrhage in the digestive tract; Patients with gastrointestinal tract anomalies, such as gastrointestinal tract atresia, or other conditions that would result in failed placement in the gastrointestinal tract; Patients with a history of bowel obstruction or related diseases in the past year; Patients with a history of systemic lupus erythematosus or scleroderma; Patients with severe infections that are not controlled, not suitable for a procedure; Patients with poor general condition and having endoscopic contraindications (as evaluated by the investigator); Pregnant women or women having the plan for pregnancy; Drug abusers or alcohol addicts or patients with uncontrollable mental illness; Patients who participated in other clinical trials of drugs or medical devices before enrollment and do not reach the endpoint time limit; Patients who participated in other clinical trials of drugs or medical devices before enrollment 3 months. Patients with any other conditions evaluated by the investigators as unsuitable for participating in the trial.

Sites / Locations

  • Beijing Friendship Hospital,Capital Medical University
  • Beijing Shijitan Hospital, Capital Medical University
  • Nanjing Drum Tower hospital
  • The First Hospital of China Medical University
  • The Affiliated Hospital of lnner Mongolia Medical University
  • Tangdu Hospital,Fouth Military Medical University
  • Tianjin Medical University General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

trial group

control group

Arm Description

In the trial group, the patients are treated with Gastric Bypass Stent System implanted under the gastroscope as well as the dietary intervention; The trial is carried out for 9 months, of which in the trial group, the patients have 3-month treatment period and then have 6-month follow-up period after the Gastric Bypass Stent System is removed.

In the control group, the patients are treated only with dietary intervention; the patients have 9-month dietary intervention in the corresponding period.

Outcomes

Primary Outcome Measures

EWL% at 3 months after device implantation procedure.
EWL%=(Preoperative weight - Weight at follow-up)/(Preoperative weight - Body weight at BMI of 25 kg/m2)*100%.

Secondary Outcome Measures

Evaluation of device use in the trial group
Gastroscopy will be performed During the procedure (Visit 2) and at device removal(Visit 5).The user assesses whether the Gastric Bypass Stent can be used successfully during the procedure. Abdominal X-ray will be performed 1 month after the implantation procedure (Visit 4) and before Gastric Bypass Stent retrieval (Visit 5). An abdominal plain film will be used to assess the status of the Gastric Bypass Stent.The stent is completely located in the duodenal bulb the stent is unfolded, and the outline is clear.
Difference in BMI change from baseline between the two groups at 1, 3, 4, 6 and 9 months after the patients are enrolled
Changes in HbA1c at 3, 6 and 9 months after the patients are enrolled
Drug dose of hypoglycemic agents at 1, 3, 4, 6 and 9 months after the patients are enrolled
Changes in blood glucose-related indicators of the patients from Baseline
Through observe the changes of (fasting insulin, fasting blood glucose, fasting C-peptide) from baseline to 1, 3, 4, 6, and 9 months to evaluate whether implanting the investigational device will bring any changes to patients' blood glucose.
Difference in blood lipid change from baseline (TC, TG, HDL-C, LDL-C) at 3, 4, 6, and 9 months after the patients are enrolled

Full Information

First Posted
June 2, 2023
Last Updated
July 3, 2023
Sponsor
Hangzhou Tangji Medical Technology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05938231
Brief Title
Tangji Gastric Bypass Stent Study for Obesity
Official Title
A Prospective, Multicenter, Randomized Controlled Clinical Study to Evaluate the Safety and Performance of the Gastric Bypass Stent System as a Weight Loss Treatment for Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
May 3, 2022 (Actual)
Study Completion Date
October 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hangzhou Tangji Medical Technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The Gastric Bypass Stent System is intended to be used in weight loss treatment for obesity in patients with a BMI ≥ 30 kg/m2. In this clinical investigation the Sponsor seeks to demonstrate the safety and performance of the Gastric Bypass Stent System for its proposed indication in weight loss treatment for obesity in the China.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
trial group
Arm Type
Experimental
Arm Description
In the trial group, the patients are treated with Gastric Bypass Stent System implanted under the gastroscope as well as the dietary intervention; The trial is carried out for 9 months, of which in the trial group, the patients have 3-month treatment period and then have 6-month follow-up period after the Gastric Bypass Stent System is removed.
Arm Title
control group
Arm Type
Other
Arm Description
In the control group, the patients are treated only with dietary intervention; the patients have 9-month dietary intervention in the corresponding period.
Intervention Type
Device
Intervention Name(s)
Gastric Bypass Stent System
Intervention Description
Subjects will be treated with the Gastric Bypass Stent System implanted under gastroscopy. Following a 3-month treatment period, the device is removed, and subjects are followed for 6 months.
Intervention Type
Behavioral
Intervention Name(s)
Dietary Intervention
Intervention Description
The patients in the trial group or in the control group,have 9-month dietary intervention in the syudy period.
Primary Outcome Measure Information:
Title
EWL% at 3 months after device implantation procedure.
Description
EWL%=(Preoperative weight - Weight at follow-up)/(Preoperative weight - Body weight at BMI of 25 kg/m2)*100%.
Time Frame
3 months after device implantation procedure
Secondary Outcome Measure Information:
Title
Evaluation of device use in the trial group
Description
Gastroscopy will be performed During the procedure (Visit 2) and at device removal(Visit 5).The user assesses whether the Gastric Bypass Stent can be used successfully during the procedure. Abdominal X-ray will be performed 1 month after the implantation procedure (Visit 4) and before Gastric Bypass Stent retrieval (Visit 5). An abdominal plain film will be used to assess the status of the Gastric Bypass Stent.The stent is completely located in the duodenal bulb the stent is unfolded, and the outline is clear.
Time Frame
Baseline visit V2 and 1, 3 months after the procedure
Title
Difference in BMI change from baseline between the two groups at 1, 3, 4, 6 and 9 months after the patients are enrolled
Time Frame
from baseline to 1, 3, 4, 6, and 9 months after the procedure.
Title
Changes in HbA1c at 3, 6 and 9 months after the patients are enrolled
Time Frame
3, 6, and 9 months after the procedure
Title
Drug dose of hypoglycemic agents at 1, 3, 4, 6 and 9 months after the patients are enrolled
Time Frame
1, 3, 4, 6, and 9 months after the procedure
Title
Changes in blood glucose-related indicators of the patients from Baseline
Description
Through observe the changes of (fasting insulin, fasting blood glucose, fasting C-peptide) from baseline to 1, 3, 4, 6, and 9 months to evaluate whether implanting the investigational device will bring any changes to patients' blood glucose.
Time Frame
from baseline to 1, 3, 4, 6, and 9 months after the procedure.
Title
Difference in blood lipid change from baseline (TC, TG, HDL-C, LDL-C) at 3, 4, 6, and 9 months after the patients are enrolled
Time Frame
from baseline to 3, 4, 6, and 9 months after the procedure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18-60 years, both male and female; Obese patients with BMI ≥ 30 kg/m2, who are willing to be treated with Gastric Bypass Stent System or dietary intervention; Patients with ASA I~II grade; The patient understands the onjective of the trial and is volunteered to participate in the trial and has signed the Informed Consent Form (ICF). Exclusion Criteria: Have a weight loss of more than 4.5 kg in the past three months, or take weight-loss drugs in the past month; Patients who used non-steroidal anti-inflammatory drugs (NSAIDs) and corticosteroids in the past month; Patients diagnosed with type 1 diabetes; Patients with the function of islet β cell basically lost, C-peptide ≤ 1/2 of the normal low limit or low and flat C-peptide release curve under glucose load; Patients with iron deficiency or iron deficiency anemia; Patients with coagulation dysfunction who used aspirin and other anticoagulants in the past month; Patients with severe liver and kidney dysfunction, and the serum creatinine concentration of greater than 180 μmol/L; Patients with Class III heart function of NYHA or higher, or pulmonary dysfunction; Patients who have undergone ERCP procedure, or have a history of cholecystitis or liver abscess; Patients with duodenal ulcer, gastric ulcer or previous and existing pancreatitis; Patients with gallstones (diameter ≥ 20 mm) with clinical symptoms; Patients with thyroid dysfunction; Patients with hemorrhage or potential hemorrhage in the digestive tract; Patients with gastrointestinal tract anomalies, such as gastrointestinal tract atresia, or other conditions that would result in failed placement in the gastrointestinal tract; Patients with a history of bowel obstruction or related diseases in the past year; Patients with a history of systemic lupus erythematosus or scleroderma; Patients with severe infections that are not controlled, not suitable for a procedure; Patients with poor general condition and having endoscopic contraindications (as evaluated by the investigator); Pregnant women or women having the plan for pregnancy; Drug abusers or alcohol addicts or patients with uncontrollable mental illness; Patients who participated in other clinical trials of drugs or medical devices before enrollment and do not reach the endpoint time limit; Patients who participated in other clinical trials of drugs or medical devices before enrollment 3 months. Patients with any other conditions evaluated by the investigators as unsuitable for participating in the trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shutian Zhang
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Friendship Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Beijing Shijitan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100038
Country
China
Facility Name
Nanjing Drum Tower hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
The Affiliated Hospital of lnner Mongolia Medical University
City
Huhehot
State/Province
Neimenggu
Country
China
Facility Name
Tangdu Hospital,Fouth Military Medical University
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Tangji Gastric Bypass Stent Study for Obesity

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