Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT02954003
Brief Summary:
The purpose of this study is to collect clinical data to support the use of the ValenTx Endo Bypass System to improve weight loss and the resolution of comorbidities in obese subjects.
Detailed Description:
* Single-arm, non-randomized, open-label, multi-center trial conducted in up to 70 subjects to assess the safety and efficacy of the ValenTx Endo Bypass System over implant duration of up to 36 months.
* Body weight, adverse events and device function in implanted subjects will be monitored at monthly visits for the first year after implant, at quarterly visits during the second year, and biannually during the third year.
* Additional follow-up data will include vital signs, hip and waist circumference, blood lab tests, endoscopic assessments of the condition of the implanted device, and a quality of life questionnaire.
* All subjects will be followed for 12 months after device removal with scheduled visits at 1, 6 and 12 months after explant.
* Subject 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 based on the condition of the implanted device.
Study:
NCT02954003
Study Brief:
Protocol Section:
NCT02954003