NCT05864911

Brief Summary

In this study, the investigators use a novel endoscopic duodenal-jejunal bypass liner-the Gastric Bypass Stent System (Hangzhou Tangji Medical Technology Co., Ltd., China) for the treatment of obesity. The aim of this study is to evaluate the efficacy and safety of this new device on weight loss and obesity-associated metabolic parameters.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
Last Updated

May 18, 2023

Status Verified

April 1, 2023

Enrollment Period

1.6 years

First QC Date

April 3, 2023

Last Update Submit

May 16, 2023

Conditions

Obesity

Keywords

The Gastric Bypass Stent Systemtotal weight lossexcess weight lossobesity

Outcome Measures

Primary Outcomes (7)

  • Change from baseline excess weight loss at 4 weeks

    excess weight loss change

    4 weeks

  • Change from baseline excess weight loss at 12 weeks

    excess weight loss change

    12 weeks

  • Change from baseline excess weight loss at 24 weeks

    excess weight loss change

    24 weeks

  • Change from baseline total weight loss at 4 weeks

    total weight loss change

    4 weeks

  • Change from baseline total weight loss at 12 weeks

    total weight loss change

    12 weeks

  • Change from baseline total weight loss at 24 weeks

    total weight loss change

    24 weeks

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Number of participants with treatment-related adverse events to assess device safety

    within 24 weeks

Secondary Outcomes (30)

  • Change from baseline body weight at 4 weeks

    4 weeks

  • Change from baseline body weight at 12 weeks

    12 weeks

  • Change from baseline body weight at 24 weeks

    24 weeks

  • Change from baseline body mass index at 4 weeks

    4 weeks

  • Change from baseline body mass index at 12 weeks

    12 weeks

  • +25 more secondary outcomes

Study Arms (1)

the Gastric Bypass Stent System group

EXPERIMENTAL

all the participants were implanted with the Gastric Bypass Stent System for 12 weeks and followed up for 24 weeks.

Device: the Gastric Bypass Stent System

Interventions

the Gastric Bypass Stent SystemDEVICE

The Gastric Bypass Stent System is a newly designed endoscopic duodenal-jejunal bypass liner for the treatment of obesity by Hangzhou Tangji Medical Technology Co., Ltd.. It consists of three main parts: a 60-cm polyethylene sleeve fixed into the duodenal bulb by anchors with barbs, a delivery system and a retrieval system. Compared to the Endobarrier, it has several technical adjustments. First, it improved sleeve materials to provide better barrier properties and reduce the breeding of bacteria resulting in hepatic abscess. Second, the barbs on the anchoring system have been modified to reduce duodenal injury. Third, the delivery and retrieval system have been optimized to eliminate the need of fluoroscopic guidance during implantation and explantation.

the Gastric Bypass Stent System group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age ≥18 and ≤60 years;
  • Body mass index ( BMI) ≥30 kg/m2;
  • American Society of Anesthesiologists( ASA) Physical Status Classification System:I-II.

You may not qualify if:

  • Weight loss of more than 4.5 kg in the past three months, or taking weight-lowering drugs in the past month;
  • Taking non-steroidal anti-inflammatory drugs (NSAIDs) or antiplatelet drugs or anticoagulant therapy in the past month;
  • Previous diagnosis with type 1 diabetes mellitus;
  • Loss of islet β-cell function, C-peptide ≤ 1/2 of the normal low limit, or low C-peptide release curve under glucose load;
  • Iron deficiency or iron deficiency anemia;
  • Severe organ dysfunction of the heart, the lung, the liver or the kidney;
  • Patients who have undergone endoscopic retrograde cholangiopancreatography, or have a history of cholecystitis, gallstones with clinical symptoms or stones larger than 20 mm in diameter; pancreatitis or hepatic abscess;
  • History of duodenal ulcer or gastric ulcer;
  • Patients with gastrointestinal bleeding or potential bleeding;
  • Digestive tract malformation, such as digestive tract atresia or previous gastrointestinal surgery that could cause failure of implantation or affect functioning of the device;
  • History of intestinal obstruction in the past year;
  • Thyroid dysfunction;
  • History of systemic lupus erythematosus or scleroderma;
  • Pregnant women or women desiring pregnancy in the next few months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (3)

  • Wang L, Zhou B, Zhao Z, Yang L, Zhang M, Jiang Y, Li Y, Zhou M, Wang L, Huang Z, Zhang X, Zhao L, Yu D, Li C, Ezzati M, Chen Z, Wu J, Ding G, Li X. Body-mass index and obesity in urban and rural China: findings from consecutive nationally representative surveys during 2004-18. Lancet. 2021 Jul 3;398(10294):53-63. doi: 10.1016/S0140-6736(21)00798-4.

    PMID: 34217401BACKGROUND

  • India State-Level Disease Burden Initiative CVD Collaborators. The changing patterns of cardiovascular diseases and their risk factors in the states of India: the Global Burden of Disease Study 1990-2016. Lancet Glob Health. 2018 Dec;6(12):e1339-e1351. doi: 10.1016/S2214-109X(18)30407-8. Epub 2018 Sep 12.

    PMID: 30219317BACKGROUND

  • Ren M, Zhou X, Yu M, Cao Y, Xu C, Yu C, Ji F. Prospective study of a new endoscopic duodenal-jejunal bypass sleeve in obese patients with nonalcoholic fatty liver disease (with video). Dig Endosc. 2023 Jan;35(1):58-66. doi: 10.1111/den.14409. Epub 2022 Aug 23.

    PMID: 35869797BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: placement of the Gastric Bypass Stent System
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2023

First Posted

May 18, 2023

Study Start

March 11, 2021

Primary Completion

October 3, 2022

Study Completion

October 3, 2022

Last Updated

May 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

The baseline demographics, the body weight changes，blood and fecal tests at each visit and the adverse effects will be available.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
The data will become available after half a year and for 3 years.
Access Criteria
all the researcher interested can get access.

Locations

CN(1)