Tangji Gastric Bypass Stent Study for Obesity

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05938231
• Other study ID #: HZTG01
• Status: Completed
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: October 7, 2022

Study information

• Verified date: June 2023
• Source: Hangzhou Tangji Medical Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: October 7, 2022
• Est. primary completion date: May 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Aged 18-60 years, both male and female;

2. Obese patients with BMI = 30 kg/m2, who are willing to be treated with Gastric Bypass Stent System or dietary intervention;

3. Patients with ASA I~II grade;

4. 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:

1. Have a weight loss of more than 4.5 kg in the past three months, or take weight-loss drugs in the past month;

2. Patients who used non-steroidal anti-inflammatory drugs (NSAIDs) and corticosteroids in the past month;

3. Patients diagnosed with type 1 diabetes;

4. Patients with the function of islet ß cell basically lost, C-peptide = 1/2 of the normal low limit or low and flat C-peptide release curve under glucose load;

5. Patients with iron deficiency or iron deficiency anemia;

6. Patients with coagulation dysfunction who used aspirin and other anticoagulants in the past month;

7. Patients with severe liver and kidney dysfunction, and the serum creatinine concentration of greater than 180 µmol/L;

8. Patients with Class III heart function of NYHA or higher, or pulmonary dysfunction;

9. Patients who have undergone ERCP procedure, or have a history of cholecystitis or liver abscess;

10. Patients with duodenal ulcer, gastric ulcer or previous and existing pancreatitis;

11. Patients with gallstones (diameter = 20 mm) with clinical symptoms;

12. Patients with thyroid dysfunction;

13. Patients with hemorrhage or potential hemorrhage in the digestive tract;

14. Patients with gastrointestinal tract anomalies, such as gastrointestinal tract atresia, or other conditions that would result in failed placement in the gastrointestinal tract;

15. Patients with a history of bowel obstruction or related diseases in the past year;

16. Patients with a history of systemic lupus erythematosus or scleroderma;

17. Patients with severe infections that are not controlled, not suitable for a procedure;

18. Patients with poor general condition and having endoscopic contraindications (as evaluated by the investigator);

19. Pregnant women or women having the plan for pregnancy;

20. Drug abusers or alcohol addicts or patients with uncontrollable mental illness;

21. Patients who participated in other clinical trials of drugs or medical devices before enrollment and do not reach the endpoint time limit;

22. Patients who participated in other clinical trials of drugs or medical devices before enrollment 3 months.

23. Patients with any other conditions evaluated by the investigators as unsuitable for participating in the trial.

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• Gastric Bypass Stent System
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.

Behavioral:
• Dietary Intervention
The patients in the trial group or in the control group,have 9-month dietary intervention in the syudy period.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital,Capital Medical University	Beijing	Beijing
China	Beijing Shijitan Hospital, Capital Medical University	Beijing	Beijing
China	The Affiliated Hospital of lnner Mongolia Medical University	Huhehot	Neimenggu
China	Nanjing Drum Tower hospital	Nanjing	Jiangsu
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Tangdu Hospital,Fouth Military Medical University	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Tangji Medical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%.	3 months after device implantation procedure
Secondary	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.	Baseline visit V2 and 1, 3 months after the procedure
Secondary	Difference in BMI change from baseline between the two groups at 1, 3, 4, 6 and 9 months after the patients are enrolled		from baseline to 1, 3, 4, 6, and 9 months after the procedure.
Secondary	Changes in HbA1c at 3, 6 and 9 months after the patients are enrolled		3, 6, and 9 months after the procedure
Secondary	Drug dose of hypoglycemic agents at 1, 3, 4, 6 and 9 months after the patients are enrolled		1, 3, 4, 6, and 9 months after the procedure
Secondary	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.	from baseline to 1, 3, 4, 6, and 9 months after the procedure.
Secondary	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		from baseline to 3, 4, 6, and 9 months after the procedure.