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OpenTrials
Completed

NCT Number: NCT02528565

Gastric Banding After Failed Gastric Bypass

The safety and efficacy of the Adhesix Bioring adjustable gastric band will be assessed in patients after failed RYGB.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ Sint Jan Brugge

Bruges, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient must sign the informed consent form prior to the index-procedure.
  • Patient with failed RYGB defined as patients with EWL <50%.

Exclusion criteria

  • Patient has a life expectancy of less than 2 year.
  • Patient who is most likely expected not to be compliant with the proposed follow-up visits.

Treatment and study plan

Adhesix Bioring

Device

Primary outcomes

  1. Percentage excess weight loss

    Time frame: 2 years

Secondary outcomes

  1. Technical success defined as laparoscopic implantation of the Adhesix Bioring as intended by the surgeon without conversion to open repair.

    Time frame: During procedure

  2. Complications (perioperative, early and late)

    Time frame: 2 years

  3. Mortality

    Time frame: 2 years

  4. Regression of co-morbidities

    Time frame: 2 years

  5. BAROS score

    Time frame: 2 years

  6. Frequency of revisions

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Duomed

Industry

Collaborators

  • Archer Research

Registry information

Official study title

Laparoscopic Adjustable Gastric Banding With the Adhesix Bioring After Failed Gastric Bypass: a Prospective Evaluation in a High-volume Center

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Aug 19, 2015
Registry last updated
Jun 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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