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The efficacy and safety of gastric bypass stent systems for weight loss treatment in overweight and obese patients---a single arm, prospective, multicenter research

The efficacy and safety of gastric bypass stent systems for weight loss treatment in overweight and obese patients---a single arm, prospective, multicenter research

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094530
Enrollment
Unknown
Registered
2024-12-24
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obesity

Interventions

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients with BMI=25 kg/m2 , who are overweight or obese, or who are obese after sleeve gastric surgery; 2. Patients understood the purpose of the trial, volunteered to participate in the trial and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Gastroscopy and surgical contraindications, including but not limited to: 1) Heart failure; 2) Persistent dyspnea; 3) Abscess of the posterior pharyngeal wall, severe spinal malformation or aortic aneurysm; 4) The body is too weak to tolerate endoscopy; 5) Acute stage of corrosive inflammation of the upper digestive tract or suspected perforation of the upper digestive tract; 6) A large number of ascites, severe abdominal distension or severe esophageal varices; 7) Abnormal blood coagulation function; 2. Patients receiving upper gastrointestinal anastomosis; 3. Tumors, active peptic ulcers and bleeding were found under endoscopy; 4. Patients with fundus hemorrhage at present; 5. Identify patients diagnosed with type 1 diabetes; 6. Patients with severe hepatic and renal dysfunction with creatinine concentration greater than 180 µmol/L; 7. Patients with intestinal obstruction or related history in the past year; 8. Patients with a history of systemic lupus erythematosus and scleroderma; 9. Pregnant women or patients trying to become pregnant; 10.Drug or alcohol addiction or uncontrollable mental illness; 11. Patients who have participated in clinical trials of other drugs or medical devices before enrollment and have not reached the end time limit;

Design outcomes

Primary

MeasureTime frame
Weight;Fasting Blood Glucose;Total weight loss;

Secondary

MeasureTime frame
2 hours Postprandial Blood Glucose;Glycosylated Hemoglobin;Gastrointestinal Symptom Rating Scale;

Countries

China

Contacts

Public ContactMeng Hua

China-Japan Friendship Hospital

menghuade@hotmail.com+86 186 1145 7779

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026