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Completed

NCT Number: NCT02072395

Gastric Plication and Banding

The purpose of the study is to assess the efficacy of a hybrid laparoscopic surgical procedure for treatment of morbid obesity, Gastric Plication (G)) and Gastric Banding.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-70
  • BMI > or = to 30 and co-morbid conditions or BMI > or = to 40
  • Ability to provide informed consent
  • Willingness to commit to long-term follow-up

Exclusion criteria

  • Inability to provide informed consent
  • Presence of metabolic or medically correctable cause(s) for obesity, such as untreated hypothyroidism or Prader-Willi
  • Contraindications to surgery such as myocardial infarction within last 6 months, end stage renal or liver disease, current infection, or other disease states contraindicative to surgery, in the principal investigator's opinion
  • Pregnancy
  • Plan to become pregnant within two years post-surgery
  • Current addiction to drugs or alcohol
  • Previous history of any type of bariatric surgery (de novo group only)
  • Hiatal hernia > 3 cm

Treatment and study plan

Plication

Procedure

Plication of the stomach will be performed in conjunction with placement of a gastric band.

Primary outcomes

  1. Weight loss

    Time frame: Two years

    The primary endpoint is weight loss two years post-surgery.

  2. Complications

    Time frame: 2 years

    Intra and post-operative complications will be tracked.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

Treatment of Morbid Obesity With Gastric Plication and Gastric Banding

Acronym: GP and Band

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Feb 26, 2014
Registry last updated
Feb 20, 2017

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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