Recruiting

Greater Curvature Plication

Sponsor:

Singh, Kuldeep, M.D., P.A.

Code:

NCT02315105

Conditions

Morbid Obesity

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Laparoscopic Greater Curvature Plication

Study Details

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.

Conditions

Morbid Obesity

Study ID

NCT02315105

Start date

Aug, 2011

Status verified date

Dec, 2014

Completion date

Aug, 2015

Anticipated

Primary completion date

Aug, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Subject is willing to give consent and comply with evaluation and treatment schedule
2. 18 to 65 years of age
3. 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
4. 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
5. HbA1C < 11 %
6. 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.
7. Ability to self-pay for the procedure and follow up.

Exclusion Criteria:

-

Study Design

Enrollment

75 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Morbid Obese patients

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.

Interventions

Laparoscopic Greater Curvature Plication

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.

Primary outcome measure

  • Percent excess weight loss [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Kuldeep Singh, MD

3014902193dockds@gmail.com

Nicole Sansbury, MPH

3014902193nsansbury@gmail.com

Locations

Saint Agnes Hospital

Recruiting

Baltimore, Maryland, United States, 21229

Contacts

Kuldeep Singh, MD

301-490-3736lapman21229@yahoo.com

Principal Investigator:

Kuldeep Singh, MD

More Information

Sponsor

Singh, Kuldeep, M.D., P.A.

Last update posted

Dec 18, 2014

Last verified

Dec, 2014

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Singh, Kuldeep, M.D., P.A. on 2014-12-18.