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The ValenTx Endo Bypass System in Obese Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
ValenTx, Inc.

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.

Condition or disease Intervention/treatment Phase
Obesity Device: Endo Bypass System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  1. Between 18- 60 years old.
  2. BMI of 40-50 kg/m2 with or without comorbidities, BMI of 35-40 kg/m2 with one or more obesity related comorbidities, or BMI of 30-35 with type 2 diabetes
  3. Willing to give informed consent, and able to understand what this means.
  4. Documented failure with non-surgical weight loss methods.
  5. Willing to follow the study procedures and comply with the visits schedule.
  6. Live within a reasonable distance of the research center and be able to attend routine follow up visits.

Exclusion Criteria

  1. Pregnancy or intention to become pregnant during the course of the study.
  2. Abnormal screening esophagogastroduodenoscopy findings
  3. Prior esophageal, gastric or bariatric surgery.
  4. Known allergies to any of the device materials.
  5. Use of weight loss drugs, stimulants and/or herbal weight loss supplements.
  6. Recent or ongoing health conditions that contraindicate undergoing an elective weight loss procedure involving a device implanted within the lumen of the esophagus, stomach and proximal small intestine.
  7. Participation in another clinical trial within 60 days of the implant.
  8. Presence of psychiatric conditions that would impair the ability to provide informed consent or to comply with study procedures.

Information from the National Library of Medicine

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


Locations
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Canada, Ontario
St. Joseph Healthcare
Hamilton, Ontario, Canada, L8N 4A6
Canada
Hopital Laval (IUCPQ)
Quebec, Canada
Mexico
Hospital San Jose Tec de Monterrey
Monterrey, NL, Mexico, 64710
Sponsors and Collaborators
ValenTx, Inc.
Investigators
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Study Director: Roland Maude-Griffin ValenTx, Inc.

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Responsible Party: ValenTx, Inc.
ClinicalTrials.gov Identifier: NCT02954003    
Other Study ID Numbers: EN 2.3
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by ValenTx, Inc.:
Obesity
Weight Loss
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms