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Plicated Laparoscopic Adjustable Gastric Banding Study

NCT ID: NCT01944111

Last Updated: 2013-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-09-30

Brief Summary

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Compare plicated laparoscopic adjustable gastric banding to standard laparoscopic adjustable gastric banding in prospective clinical trial.

Detailed Description

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This is a prospective clinical trial comparing experimental plicated adjustable gastric banding versus standard adjustable gastric banding. All enrolled patients will choose to either standard (control group) banding or plication (study group) banding. Each patient will complete a standardized survey rating their satisfaction from surgery, their satiety levels and Green Zone Patient Questionnaire at each visit.

Conditions

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Weight Loss

Keywords

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Gastric plication

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Plication

Prospective clinical trial comparing Standard Adustable Gastric Banding versus experimental Adjustable Gastric Banding

Group Type EXPERIMENTAL

Plication

Intervention Type DEVICE

Prospective clincial trial comparing adjustable gastric banding with plication versus standard adjustable gastric banding. Variables to be studied include patient age, gender, ethnicity, co-morbid disease conditions, height, weight, BMI, intra-operative data such as operative time and blood loss and post-operative outcomes including length of hosptial stay, complication rates, weight loss, and co-morbid disease resolution.

Interventions

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Plication

Prospective clincial trial comparing adjustable gastric banding with plication versus standard adjustable gastric banding. Variables to be studied include patient age, gender, ethnicity, co-morbid disease conditions, height, weight, BMI, intra-operative data such as operative time and blood loss and post-operative outcomes including length of hosptial stay, complication rates, weight loss, and co-morbid disease resolution.

Intervention Type DEVICE

Other Intervention Names

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Lap Band Plication Adjustable gastric Banding with Plication

Eligibility Criteria

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Inclusion Criteria

* Age older than 18 years
* Morbidly Obese
* BMI \>40 or
* BMI \>35 plus co-morbid obesity related disease conditions
* Without contraindications to bariatric surgery: eg pregnancy, desire to become pregnant within the next 12 months, myocardial infarct within the last 6 months, cancer within last 5 years, end stage renal/liver disease
* Without any metabolic or medically correctable causes for obesity: eg untreated hypothyroidism, Prader-Willi

* Patients with any major medical problems contraindicating surgery
* Patients with a medically treatable cause of obesity
* Patients who elect to undergo a surgery other than Plication adjustable gastric banding or standard adjustable gastric banding
* Alcohol or drug addiction
* Established infection anywhere in the body at the time of surgery
* Previous history of bariatric surgery, intestinal obstruction, or adhesive peritonitis
* Family or patient history of autoimmune disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tenet Healthcare Corporation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James S Scott, MD

Role: PRINCIPAL_INVESTIGATOR

Tenet Healthcare Corporation

Locations

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Des Peres Hospital

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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2315-1

Identifier Type: -

Identifier Source: org_study_id