Gastric Restriction Using the EndoSurgical Operating System

USGI Medical

Status

Terminated

Conditions

Obesity

Treatments

Device: Using the EOS for gastric restriction

Study type

Interventional

Funder types

Industry

Identifiers

NCT01661608

TPR41122

Details and patient eligibility

About

The primary objective is to collect data on the use of the EndoSurgical Operating System (EOS) for gastric tissue approximation during primary gastric restrictive procedures.

Enrollment

32 patients

Sex

All

Ages

20 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patient has met diabetic lab testing and all pre-procedural qualifications as delineated below.
Patient is >/= 20 yrs. of age and </= 60 yrs. of age
Patient has a BMI of >/=30 and < 40
Patient has history of obesity for >/= 2 yrs.
Patient has had not significant weight change (<5% of total body weight) in last 6 months.
Patient is a reasonable candidate for general anesthesia
Patient agrees not to have any additional weight loss surgery or liposuction for 2 yrs. following procedure.

Exclusion criteria

Patient is not able and willing to return for all follow-up evaluations, tests and nutritional counseling.
Patient is not able to provide written informed consent
Patient has history or present use of insulin or insulin derivatives for treatment of diabetes.
Patient has diabetes secondary to a specific disease.
Patient has history of inflammatory disease of GI tract
Patient has diabetic retinopathy
Patient has chronic pancreatic disease
Patient ahs active peptic ulcer
Patient has portal hypertension
Patient has esophageal varices
Patient has significant esophageal disease
Patient has a history of any significant abdominal surgery
Patient has a history of any bariatric or GERD surgical procedures
Patient has a hiatal hernia > 2cm.
Patient has esophageal stricture or other anatomy and/or condition that could preclude passage of endolumenal instruments
Patient is of childbearing age and not practicing effective birth control method, pregnant or lactating.
Patient has had a MI or CVA in last year, or has unstable cardiovascular disease.
Patient has cancer or life expectancy of < 2 yrs.
Patient currently uses or has used over the counter or prescription weight loss drugs in last month or intends to use during follow-up Registry period.
Patient has quit smoking within last 6 months or plans to quit smoking in the next year.
Patient has a history of durg or alcohol abuse
Patient has uncontrolled depression, psychosis, or eating disorder.
Patient is non-ambulatory or has significant impairment of mobility.
Patient has known hormonal or genetic cause for obesity.
Patient is participating in another Registry and/or Study that could adversely affect this Registry.