Prospective, single-center, non-randomized, open label, single arm study to demonstrate the safety and performance of GDS (Gastro-Duodenal Sleeve) system. - GDS Study

Allevetix Ltd0 个研究点目标入组 10 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•This study will include subjects who meet all of the following:
•1.Both male and female patients
•2.Patient is at least 18 years old
•3.Anticipated patient life expectancy of at least 1 year from enrolment
•4.Patient providing written Informed Consent Form to participate in the study prior to any study related procedures
•5.Patient is willing to comply with the protocol requirements and return to the study center for all required clinical evaluations
•6.Patient Baseline BMI of >= 30 kg/m2 and <= 45 kg/m2
•7.Type 2 diabetes mellitus with HbA1c >= 8 in the 6 months before enrolment
•8.Sexually active women, unless surgically sterile or post menopausal, must use one of the following methods to avoid pregnancy during the study: 1. Abstinence from penile/vaginal intercourse during the study; 2. Double barrier contraceptive methods 1 of which must be condom.

•The patients will be excluded from the study based on the following exclusion criteria:
•1.Use of weight loss medications or appetite suppressants since last 1 month
•2.Use of non-steroidal anti-inflammatory drugs, corticosteroids, and drugs known to affect gastrointestinal motility since last 3 month
•3.Pancreatitis in the last 1 month, symptomatic coronary artery disease (NYHA <3), COPD, known biliary disease (gallstone, choledocholithiasis), severe coagulopathy
•4.History of gastrointestinal tract abnormalities, including gastrointestinal bleeding conditions
•5.Patients having anemia/ iron deficiency
•6.Patient with known peptic ulcer, gastritis, duodenitis, esophagitis, varices
•7.History or symptoms of scleroderma
•8.Previous surgery in the gastrointestinal tract that could affect the ability to place the study device
•9.Current infection
•10.Any malignancy
•11.HIV, HCV, HBV positive
•12.Alcohol abuse
•13.Congenital or acquired abnormalities of the gastrointestinal tract
•14.Pregnant female or intention to become pregnant within the next 16 weeks
•15.Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the patient to participate in the study
•16.Patient should not take anti-coagulants and/or anti-aggregates for 10 days prior the device placement.

发起方

Allevetix Ltd