NCT02315105

Brief Summary

The purpose of this study is to find out more about the safety and effectiveness of the Laparoscopic Greater Curvature Plication (LGCP) procedure in patients with obesity and related problems such as diabetes, hypertension, high cholesterol, mild obstructive sleep apnea, and joint problems. LGCP is a less invasive weight loss surgery procedure than some of the other weight loss surgeries and it is possible that there are fewer risks with this procedure than with the other weight loss surgeries. LGCP is considered an experimental procedure and this study is being done to look at the long-term outcomes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

December 18, 2014

Status Verified

December 1, 2014

Enrollment Period

4 years

First QC Date

December 9, 2014

Last Update Submit

December 17, 2014

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (1)

  • Percent excess weight loss

    1 year

Secondary Outcomes (1)

  • Resolution of Comorbidities

    1 year

Study Arms (1)

Morbid Obese patients

EXPERIMENTAL

This purpose of this study is to find out more about the safety and effectiveness of the Laparoscopic Greater Curvature Plication (LGCP) for Morbid Obese Patients with related problems such as diabetes, hypertension, high cholesterol, mild obstructive sleep apnea and joint problems.

Procedure: Laparoscopic Greater Curvature Plication

Interventions

Laparoscopic Greater Curvature PlicationPROCEDURE

LGCP is a procedure in which the stomach is folded inwards to that its capacity to hold amount of food is decreased dramatically. This is done under general anesthesia. The operation takes about 1 hour and is done laparoscopically. The attachments of the stomach to the spleen are feed up and the outside is folded inside and stitched up to keep it from folding in. To ensure that the surgeon has not obstructed the passage in or out of the stomach, a tube ( Bougie) is placed in the stomach at the time of the creation of the fold and checked again at the end of the procedure with a camera in the stomach which is placed through the mouth (EGD- upper endoscopy) to ensure the desired outcome is achieved.

Morbid Obese patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is willing to give consent and comply with evaluation and treatment schedule
  • to 65 years of age
  • Have a BMI \> 30 with one or more significant co-morbid medical conditions which are generally expected to be improved, reversed, or resolved by weight loss. these conditions include but are not limited to:
  • Hyperlipidemia
  • Type 2 diabetes
  • Mild Obstructive Sleep Apnea
  • Hypertension
  • Osteoarthritis of the hip or knee
  • 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
  • HbA1C \< 11 %
  • For subjects who have Type 2 Diabetes, the anti-diabetic medication regimen is no more complex than oral metformin plus one oral sulfonylurea plus once daily insulin injection.
  • Ability to self-pay for the procedure and follow up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Agnes Hospital

Baltimore, Maryland, 21229, United States

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kuldeep Singh, MD

    Saint Agnes Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuldeep Singh, MD

CONTACT

3014902193dockds@gmail.com

Nicole Sansbury, MPH

CONTACT

3014902193nsansbury@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2014

First Posted

December 11, 2014

Study Start

August 1, 2011

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

December 18, 2014

Record last verified: 2014-12

Locations

US(1)