The ePass Clinical Trial for the Treatment of Obese Subjects

ValenTx

Status

Unknown

Conditions

Obesity

Treatments

Device: ePass

Study type

Interventional

Funder types

Industry

Identifiers

NCT02954016

EP 1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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