Feasibility Trial of ValenTx Endo Bypass System of the ValenTx Endo Bypass System in Obese Subjects

NCT ID: NCT01207830

Last Updated: 2016-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2012-02-29

Brief Summary

The purpose of this study is to provide initial clinical data to support the feasibility of use of the ValenTx Endo Bypass system in enhancing weight loss and co-morbidity resolution in morbidly obese subjects

Detailed Description

This is a single center, open label, feasibility study whose major aim is to determine the feasibility (based on safety, efficacy and device performance) of the ValenTx Endo Bypass system with the replaceable sleeve. Also, the use of a tag replacement device may be developed and implemented should individual attachment tags need replaced following the initial implant.

Conditions

Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endo Bypass

Subjects implanted with the investigational ValenTx Endo Bypass System

Group Type: EXPERIMENTAL

Endo Bypass System

Intervention Type: DEVICE

Subject is implanted with the device for up to 3 years.

Interventions

Endo Bypass System

Subject is implanted with the device for up to 3 years.

Intervention Type: DEVICE

Other Intervention Names

Valentx; EBS

Eligibility Criteria

Inclusion Criteria

• Male or female between 18 and 55 years of age
• Subject has a BMI >35 kg/m2 and <= 50 kg/m2, with or without co-morbid conditions(s)
• Documented failure with non-surgical weight loss methods
• Willing to comply with study procedures and visit schedule
• Willing and able to provide informed consent

Exclusion Criteria

• Pregnancy or intention of becoming pregnant within the study duration (Women of childbearing potential participating in the study must have a negative serum pregnancy test result at screening and use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used double-barrier contraception, eg condom plus diaphragm. If screening pregnancy test is done greater than 7 days before implant, women of childbearing potential must have another serum pregnancy test result before implantation. Any woman becoming pregnant during the treatment period must withdraw from the study)
• Endoscopic lesions such as important hiatal hernia, gastric or duodenal ulcer, atresias or stenosis, polyps of the stomach
• Subject with potential upper gastrointestinal bleeding such as esophageal or gastric varices, Mallory-Weis syndrome or congenital or acquired intestinal telangiectasia
• Past history of esophageal or gastric/GI surgery, obstruction, adhesive peritonitis, or large hiatal hernia (> 3 cm)
• IBS, unexplained intermittent vomiting, severe abdominal pain or chronic constipation within 60 days of study day 0
• Unexplained anaemia, Pancreatitis, Portal hypertension, Esophagitis or Barrett's esophagus, known gallstones or anomalies of the GI tract
• Any bodily infections within 30 days of study day 0 (implant day)
• Prolonged steroid use
• Hep C or HIV positive
• Known allergies to any of the device materials
• Use of weight loss medication within 2 months prior to enrollment and throughout the study period
• Recent or ongoing cancer, history of severe renal, hepatic, cardiovascular or pulmonary disease or transplants
• Inability to tolerate anti-inflammatory medications
• Evidence of psychiatric problems or dietary habits that would contraindicate study treatment
• Active drug or alcohol addiction within 12 months of enrollment and throughout the study duration
• Prior history of inflammatory diseases of the GI tract, (e.g., esophagitis, varices, gastric or duodenal ulceration, or Crohn's disease; congenital or acquired GI anomalies, e.g., bowel strictures)
• Ongoing treatment with anticoagulants, steroids, aspirin, NSAIDs, or other gastric irritants within 1 month prior to enrollment and throughout the study period
• Participation in previous (within 60 days of study day 0) or ongoing clinical trial or current or past usage (within 60 days of study day 0) of investigation drug or other device

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ValenTx, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roberto Rumbaut, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hospital San Jose Tec

Locations

Hospital San Jose Tec de Monterrey

Monterrey, , Mexico

Countries

Mexico

References

Sandler BJ, Rumbaut R, Swain CP, Torres G, Morales L, Gonzales L, Schultz S, Talamini MA, Jacobsen GR, Horgan S. One-year human experience with a novel endoluminal, endoscopic gastric bypass sleeve for morbid obesity. Surg Endosc. 2015 Nov;29(11):3298-303. doi: 10.1007/s00464-015-4081-5. Epub 2015 Jan 29.

Reference Type: DERIVED

PMID: 25631114 (View on PubMed)

Other Identifiers

LA 2.2

Identifier Type: -

Identifier Source: org_study_id