Tangji Gastric Bypass Stent Study for Obesity

NCT05938231 | Completed

• 1 other identifier: HZTG01
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 7

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Evaluation of device use in the trial group

  Baseline visit V2 and 1, 3 months after the procedure

• 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.

• Changes in HbA1c at 3, 6 and 9 months after the patients are enrolled

  3, 6, and 9 months after the procedure

• 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

• Changes in blood glucose-related indicators of the patients from Baseline

  from baseline to 1, 3, 4, 6, and 9 months after the procedure.

Study Arms (2)

trial group

EXPERIMENTAL

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.

Device: Gastric Bypass Stent System; Behavioral: Dietary Intervention

control group

OTHER

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

Behavioral: Dietary Intervention

Interventions

Gastric Bypass Stent System DEVICE

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.

trial group

Dietary Intervention BEHAVIORAL

The patients in the trial group or in the control group,have 9-month dietary intervention in the syudy period.

control group; trial group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hangzhou Tangji Medical Technology Co., Ltd.: lead

Study Sites (7)

Beijing Friendship Hospital,Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

Beijing Shijitan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100038, China

Location

Nanjing Drum Tower hospital

Nanjing, Jiangsu, 210000, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, China

Location

The Affiliated Hospital of lnner Mongolia Medical University

Hohhot, Neimenggu, China

Location

Tangdu Hospital,Fouth Military Medical University

Xi’an, Shanxi, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300000, China

Location

MeSH Terms

Conditions

Obesity

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Shutian Zhang

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: July 10, 2023
• Study Start: March 15, 2021
• Primary Completion: May 3, 2022
• Study Completion: October 7, 2022
• Last Updated: July 10, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)