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Search / Trial NCT01703546

Weight Loss & Comorbidity Resolution With LAGB Alone vs. LAGB With Gastric Plication

Launched by NORTHWELL HEALTH · Oct 8, 2012

Trial Information

Current as of June 18, 2025

Completed

Keywords

Morbid Obesity Weight Loss Surgery Laparoscopic Adjustable Gastric Band Laparoscopic Gastric Plication Imbrication

ClinConnect Summary

Laparoscopic Adjustable Gastric Banding when combined with gastric plication will provide lasting weight loss benefits to patients. We are projecting that the percent of Excess Body Weight Loss (% EWL) will be greater in study subjects when compared with our control group with LAGB alone. Furthermore, it is anticipated that the % EWL in study subjects will be similar to patients who have laparoscopic Roux-En-Y Gastric Bypass.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Body Mass Index (BMI) \> 35
  • Meet ASMBS and NIH criteria for Weight Loss Surgery
  • ASA Class I - III
  • Agree to refrain from any type of weight-loss drug (prescription or OTC)or elective procedure that would affect body weight for the duration of the trial.
  • English speaking \& comprehension
  • Normal mental caliber.
  • Exclusion Criteria:
  • Pregnancy, Liver failure or Kidney failure
  • Women of childbearing potential lactating at the time of initial consult or at the time of surgery
  • Any condition which precludes compliance with the study
  • History or presence of pre-existing autoimmune connective tissue disease or cancer must be evaluated on a case by case basis by the Director of Bariatric Surgery.

About Northwell Health

Northwell Health is a leading integrated health system based in New York, dedicated to advancing healthcare through innovative research and clinical trials. With a commitment to improving patient outcomes and enhancing medical knowledge, Northwell Health conducts a diverse range of clinical studies across various therapeutic areas. The organization harnesses its extensive network of hospitals, outpatient facilities, and research institutes to facilitate cutting-edge research, ensuring access to advanced treatments for patients while fostering collaboration among healthcare professionals, researchers, and industry partners. By prioritizing patient-centric approaches and leveraging state-of-the-art technology, Northwell Health aims to drive significant advancements in medical science and public health.

Locations

Syosset, New York, United States

Syosset, New York, United States

Patients applied

0 patients applied

Trial Officials

Robert Ward, MD

Study Chair

North Shore LIJ Health System, Syosset Hospital, Director of Surgery

Allison Barrett, MD

Principal Investigator

North Shore LIJ Health System Syosset Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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