The ePass Clinical Trial for the Treatment of Obese Subjects (ePass)

November 1, 2016 updated by: ValenTx, Inc.

Safety and Efficacy of the ValenTx EndoPass™ System for the Treatment of Obese Subjects: The ePass Clinical Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  • Single-arm, multi-center study conducted in up to 50 subjects at up to 5 sites.
  • Subjects will be implanted with the EndoPass device for up to 36 months.
  • Body weight, adverse events and device function will be monitored at monthly visits for the first year after implant and quarterly visits thereafter.
  • Additional follow-up data will include vital signs, hip and waist circumference, blood lab tests, endoscopic and esophagram assessments of the condition of the implanted device, quality of life and eating behavior questionnaires.
  • All subjects will be followed for 12 months after device removal.
  • A single device renewal may take place as needed after the initial implant.
  • Subject study participation may last up to four years, but is expected to vary with implant duration, which will be determined on a case-by-case basis.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Mendoza, Argentina, 5500
        • Hospital Italiano de Mendoza / Clinica Quiriurgica
  • Mexico
    • NL
      • Monterrey, NL, Mexico
        • Swiss Hospital / Especialidades Bariatrices

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • 18-60 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

Key Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ePass
Subjects implanted with the investigational ValenTx Endo Bypass System
Device: ePass
Subject is implanted with the device for up to 3 years.
Other Names:
  • ValenTx
  • Endo Bypass System
  • EBS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of subjects affected by serious adverse device effects (SADEs) as defined by International Standards Organization (ISO) standard 14155:2011.
Time Frame: 1 Year
The proportion of subjects affected by SADEs during the 12 months following their device implant
1 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
12 Month Weight Loss in Kilograms
Time Frame: 1 Year
Mean reduction in bodyweight in kilograms from the day of implant to the 12 month post-implant follow-up visit.
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ValenTx, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

September 23, 2016

First Submitted That Met QC Criteria

November 1, 2016

First Posted (Estimate)

November 3, 2016

Study Record Updates

Last Update Posted (Estimate)

November 3, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EP 1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on ePass

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe