The ValenTx Endo Bypass System in Obese Subjects
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|ClinicalTrials.gov Identifier: NCT02954003|
Recruitment Status : Unknown
Verified November 2016 by ValenTx, Inc..
Recruitment status was: Active, not recruiting
First Posted : November 3, 2016
Last Update Posted : November 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Device: Endo Bypass System||Not Applicable|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Trial of the Safety and Effectiveness of the ValenTx Endo Bypass System and Use of the Endoscopic Anchor Placement Device in Obese Subjects|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||October 2018|
Experimental: Endo Bypass
Subjects implanted with the investigational ValenTx Endo Bypass System
Device: Endo Bypass System
Subject is implanted with the device for up to 3 years.
Other Name: ValenTx System
- 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 ]The proportion of subjects affected by SADEs during the 12 months following their device implant.
- Mean 12 Month Weight Loss in Kilograms [ Time Frame: 1 Year ]Mean reduction in bodyweight in kilograms from the pre-implant baseline visit to the 12 month post-implant follow-up visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02954003
|St. Joseph Healthcare|
|Hamilton, Ontario, Canada, L8N 4A6|
|Hopital Laval (IUCPQ)|
|Hospital San Jose Tec de Monterrey|
|Monterrey, NL, Mexico, 64710|
|Study Director:||Roland Maude-Griffin||ValenTx, Inc.|