The ePass Clinical Trial for the Treatment of Obese Subjects

NCT02954016 | Unknown DMC

• 1 other identifier: EP 1.0
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 2

Brief Summary

To evaluate the safety and efficacy of the endoscopically implanted ValenTx EndoPass™ System for treatment of adults with severe obesity. The EndoPass System is indicated for weight loss in adults with a body mass index (BMI) ≥35 and ≤ 50 kg/m2 who have failed more conservative weight loss methods.

Conditions

Obesity

Keywords

Obesity; Weight Loss; Hypertension; Type 2 Diabetes Mellitus; Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• The proportion of subjects affected by serious adverse device effects (SADEs) as defined by International Standards Organization (ISO) standard 14155:2011.

  The proportion of subjects affected by SADEs during the 12 months following their device implant

  1 Year

Secondary Outcomes (1)

• 12 Month Weight Loss in Kilograms

  1 Year

Study Arms (1)

ePass

EXPERIMENTAL

Subjects implanted with the investigational ValenTx Endo Bypass System

Device: ePass

Interventions

ePass DEVICE

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

Also known as: ValenTx, Endo Bypass System, EBS

ePass

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age.
• BMI ≥ 35 and ≤ 50 kg/m2
• Documented failure with non-surgical weight loss methods
• Self-reported maximum and minimum body weights during the past 12 months within 10% of current body weight

You may not qualify if:

• Pregnancy or intention of becoming pregnant.
• Past history of esophageal, gastric or bariatric surgery.
• Medical conditions contraindicating elective endoscopic or bariatric procedures.
• Insulin-dependent diabetes mellitus

Sponsors & Collaborators

• ValenTx, Inc.: lead

Study Sites (2)

Hospital Italiano de Mendoza / Clinica Quiriurgica

Mendoza, 5500, Argentina

Location

Swiss Hospital / Especialidades Bariatrices

Monterrey, Nuevo León, Mexico

Location

MeSH Terms

Conditions

Obesity; Weight Loss; Hypertension; Diabetes Mellitus, Type 2; Hyperlipidemias

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Dyslipidemias; Lipid Metabolism Disorders

Study Officials

• Roland Maude-Griffin

  ValenTx, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: November 3, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2022
• Last Updated: November 3, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1); ME (1)