Plicated Laparoscopic Adjustable Gastric Banding Study

NCT01944111 | Unknown Phase 1

• 1 other identifier: 2315-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Weight Loss

Keywords

Gastric plication

Outcome Measures

Primary Outcomes (1)

• Weight loss

  Weight loss 4 weeks post surgical:20% additional than without plication, 3months post surgical: 30% additional than without plication, 6 months post surgical:30-40% additional than without plication, 1 year post surgical = 30-40% additional than without plication \& at 1 year patient will require 50% fewer adjustments than without plication.

  at least 1 year

Study Arms (1)

Plication

EXPERIMENTAL

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

Device: Plication

Interventions

Plication 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.

Also known as: Lap Band Plication, Adjustable gastric Banding with Plication

Plication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tenet Healthcare Corporation: lead

Study Sites (1)

Des Peres Hospital

St Louis, Missouri, 63122, United States

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• James S Scott, MD

  Tenet Healthcare Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2013
• First Posted: September 17, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 17, 2013

Record last verified: 2013-09

Locations

US (1)