Tangji EU Gastric Bypass Stent Study for Obesity

NCT05249608 | Unknown DMC

• 1 other identifier: BL-RD08-040
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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 European Union (EU) and United Kingdom (UK).

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Performance（EFFICACY） Endpoint:

  1\) Extra weight loss percentage (EWL%) at 3 months after device implantation procedure.

  3 months after device implantation procedure

Secondary Outcomes (8)

• Use abdominal X-ray evaluate Device implantation status

  V1-V5(90±7 days)

• Performance（EFFICACY） Endpoint:

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

• Performance（EFFICACY） Endpoint:

  3, 6, and 9 months after the procedure.

• Performance（EFFICACY） Endpoint:

  at 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.

Other Outcomes (2)

• Occurrence numbers of the Clinically significant changes of laboratory tests throughout the clinical investigation.

  Through out the whole study V1-V8(9 months after the procedure)

• Occurrence numbers of complications associated with the investigational device and the procedure.

  Through out the whole study V1-V8(9 months after the procedure)

Study Arms (1)

Single arm

OTHER

A single arm study, only investigational product-the Gastric Bypass Stent System is intended to be used in weight loss treatment for obesity in patients with a BMI ≥ 30 kg/m2. to evaluate the safety and performance of the investigational device for the intended use.

Device: A prospective, open-label, multicenter, single-arm clinical study to evaluate the safety and performance of the Gastric Bypass Stent System as a weight loss treatment for obesity

Interventions

A prospective, open-label, multicenter, single-arm clinical study to evaluate the safety and performance of the Gastric Bypass Stent System as a weight loss treatment for obesity DEVICE

This study includes 3 phases; screening period, procedural period, and a follow-up period. Following a 2-week screening period, subjects will be treated with the Gastric Bypass Stent System implanted under gastroscopy (Visit 2; Day 0). Following a 3-month treatment period, the device is removed, and subjects are followed for 6 months. In total subject participation will last for approximately 9 months.

Single arm

Eligibility Criteria

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

You may qualify if:

• Adult male and female aged 18 to 60 years old.
• Obese patients with BMI ≥ 30 kg/m2, who are willing to be treated with Gastric Bypass Stent System.
• Patients with American Society of Anesthesiologists (ASA) I\~II grade. Exception: patients with BMI ≥ 40 kg/m2 may be included upon the Investigator's discretion if they have no other severe systemic disease.
• Able and willing to provide informed consent for participation in the clinical investigation and comply with all study procedures and assessments.

You may not qualify if:

• Have lost more than 4.5 kg in the past three months or have taken weight loss drugs in the past month.
• Patients with secondary obesity; a medical condition that has caused weight gain such as endocrine disorders and hypothalamic disorders.
• Chronic, daily use of systemic anti-inflammatory or corticosteroid medications (e.g., ibuprofen, prednisolone) for more than 1 week (not including low-dose aspirin for cardiac prophylaxis or inhaled corticosteroids).
• Patients with less than one-year continuous treatment before baseline with hypoglycemic drugs with known weight loss effects (e.g., GLP-1 agonists, SGLT-2 inhibitors, DDP-4 inhibitors).
• 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 significant iron deficiency or iron deficiency anemia upon the Investigator's discretion.
• Patients with coagulation dysfunction and chronic, daily use of systemic anti-inflammatory or anti-coagulation medication in the past month (not including low-dose aspirin).
• Patients with severe liver and kidney dysfunction, and a serum creatinine concentration ≥ 180 μmol/L.
• Patients with Class III heart function of New York Heart Association Functional Classification (NYHA) or higher upon the Investigators evaluation.
• Patients with pulmonary dysfunction upon the Investigator's evaluation.
• Patients who have undergone Endoscopic Retrograde Cholangiopancreatography (ERCP) or have a history of cholecystitis or liver abscess.
• Patients with a duodenal ulcer, gastric ulcer, or previous and existing pancreatitis.
• Patients with gallstones (diameter ≥ 20 mm) with clinical symptoms.
• Patients with on-going thyroid dysfunction, not stabilized despite appropriate treatment.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Obesity

Interventions

Adiposity

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Body Fat Distribution; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Body Composition; Biochemical Phenomena; Chemical Phenomena; Metabolism; Physiological Phenomena

Study Design

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

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: February 21, 2022
• Study Start: June 1, 2023
• Primary Completion: February 2, 2025
• Study Completion: June 1, 2025
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share