Back to resultsThe ePass Clinical Trial for the Treatment of Obese Subjects (ePass)
Primary Purpose
Obesity
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ePass
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Weight Loss, Hypertension, Type 2 Diabetes Mellitus, Hyperlipidemia
Eligibility Criteria
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
Sites / Locations
- Hospital Italiano de Mendoza / Clinica Quiriurgica
- Swiss Hospital / Especialidades Bariatrices
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ePass
Arm Description
Subjects implanted with the investigational ValenTx Endo Bypass System
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
12 Month Weight Loss in Kilograms
Mean reduction in bodyweight in kilograms from the day of implant to the 12 month post-implant follow-up visit.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02954016
Brief Title
The ePass Clinical Trial for the Treatment of Obese Subjects
Acronym
ePass
Official Title
Safety and Efficacy of the ValenTx EndoPass™ System for the Treatment of Obese Subjects: The ePass Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ValenTx, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Weight Loss, Hypertension, Type 2 Diabetes Mellitus, Hyperlipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ePass
Arm Type
Experimental
Arm Description
Subjects implanted with the investigational ValenTx Endo Bypass System
Intervention Type
Device
Intervention Name(s)
ePass
Other Intervention Name(s)
ValenTx, Endo Bypass System, EBS
Intervention Description
Subject is implanted with the device for up to 3 years.
Primary Outcome Measure Information:
Title
The proportion of subjects affected by serious adverse device effects (SADEs) as defined by International Standards Organization (ISO) standard 14155:2011.
Description
The proportion of subjects affected by SADEs during the 12 months following their device implant
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
12 Month Weight Loss in Kilograms
Description
Mean reduction in bodyweight in kilograms from the day of implant to the 12 month post-implant follow-up visit.
Time Frame
1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland Maude-Griffin
Organizational Affiliation
ValenTx, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Italiano de Mendoza / Clinica Quiriurgica
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Facility Name
Swiss Hospital / Especialidades Bariatrices
City
Monterrey
State/Province
NL
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The ePass Clinical Trial for the Treatment of Obese Subjects
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