The ePass Clinical Trial for the Treatment of Obese Subjects

Obesity Clinical Trial

— ePass  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02954016
• Other study ID #: EP 1.0
• Status: Active, not recruiting
• Phase: N/A
• First received: September 23, 2016
• Last updated: November 1, 2016
• Start date: March 2016
• Est. completion date: March 2022

Study information

• Verified date: November 2016
• Source: ValenTx, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Coordinación de Investigación en SaludArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: March 2022
• Est. primary completion date: March 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• ePass
Subject is implanted with the device for up to 3 years.

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Mendoza / Clinica Quiriurgica	Mendoza
Mexico	Swiss Hospital / Especialidades Bariatrices	Monterrey	NL

Sponsors (1)

Lead Sponsor	Collaborator
ValenTx, Inc.

Countries where clinical trial is conducted

Argentina,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	1 Year	No