Status:
UNKNOWN
Resolution of Comorbidities, Safety and Efficacy of Greater Curvature Plication in Obese Patients.
Lead Sponsor:
Singh, Kuldeep, M.D., P.A.
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Various gastric restrictive procedures have evolved over the years but abandoned due to poor long term weight loss, food intolerance or severe gastroesophageal reflux. Laparoscopic gastric plication o...
Detailed Description
Since the acceptance of surgical procedures to achieve a sustainable weight loss, many different procedures has been tried with variable success. Among them , various gastric restrictive procedures ha...
Eligibility Criteria
Inclusion
- Subject is willing to give consent and comply with evaluation and treatment schedule;
- 18 to 65 years of age (inclusive);
- Have a BMI \> 27 with one or more significant co-morbid medical conditions which are generally expected to be improved, reversed, or resolved by weight loss. These conditions may include but are not be 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.
Exclusion
- Previous malabsorptive or restrictive procedures performed for the treatment of obesity;
- Scheduled concurrent surgical procedure, with the exception of SOC liver biopsy;
- Women of childbearing potential who are pregnant or lactating at the time of screening or at the time of surgery;
- Any condition which precludes compliance with the study;
- History or presence of pre-existing autoimmune connective tissue disease
- Use of prescription or over the counter weight reduction medications or supplements within thirty days of the Screening Visit or the duration of study participation.
- Psychiatric disorders that may affect compliance with the clinical trial, including dementia, active psychosis, severe depression requiring \> 2 medications, or history of suicide attempts. Any condition which places the subject at undue risk for the procedure (surgeon's discretion).
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01512940
Start Date
October 1 2011
End Date
October 1 2014
Last Update
March 13 2012
Active Locations (1)
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1
Saint Agnes Hospital
Baltimore, Maryland, United States, 21229