The ePass Clinical Trial for the Treatment of Obese Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 14 November 2016
• Main ID: NCT02954016
• Date of registration: 23/09/2016
• Prospective Registration: No
• Primary sponsor: ValenTx, Inc.
• Public title: The ePass Clinical Trial for the Treatment of Obese Subjects ePass
• Scientific title: Safety and Efficacy of the ValenTx EndoPass™ System for the Treatment of Obese Subjects: The ePass Clinical Trial
• Date of first enrolment: March 2016
• Target sample size: 10
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02954016
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Argentina, Mexico

Contacts

• Name: Roland Maude-Griffin
• Affiliation: ValenTx, Inc.

Key inclusion & 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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Obesity

Intervention(s)

Device: ePass

Primary Outcome(s)

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]

Secondary Outcome(s)

12 Month Weight Loss in Kilograms [Time Frame: 1 Year]

Secondary ID(s)

EP 1.0

Source(s) of Monetary Support

Please refer to primary and secondary sponsors