Clinical trial NCT01661608: Gastric Restriction Using the EndoSurgical Operating System
Official title: Gastric Restriction Using the EndoSurgical Operating System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Keywords: Gastric Restriction
Lead sponsor: USGI Medical
Sponsor class: INDUSTRY
First posted: 2012-08-09
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Evaluation in regards to Weight Loss
timeFrame: 24 Months Post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Bluegrass
state: Kentucky
city: New Orleans
country: United States
facility: SSL
state: Louisiana
city: Boston
country: United States
facility: Brigham & Womens
state: Massachusetts
city: Charlotte
country: United States
facility: Presbyterian
state: North Carolina
city: Mexico City
country: Mexico
facility: Mexico
Study officials:
affiliation: SSL
name: Michael J. Thomas, MD, FACS
role: PRINCIPAL_INVESTIGATOR
affiliation: SSL
name: Thomas Lavin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Presbyterian
name: David Voelinger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bluegrass
name: Peter Denk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham & Womans
name: Christopher Thompson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCSD
name: Santiago Horgan, MD
role: PRINCIPAL_INVESTIGATOR
References: