ULTIMATE Study for Weight Loss

USGI Medical

Status

Completed

Conditions

Obesity

Treatments

Device: g-Cath Suture Anchor Delivery Catheter

Study type

Interventional

Funder types

Industry

Identifiers

NCT01771276

TPR602

Details and patient eligibility

About

The purpose of this study is to help find out more about how the Primary Obesity Surgery Endoluminal (POSE) procedure makes patients feel less hungry and fuller faster, leading to weight loss. In this study, USGI Medical wants to see if stomach emptying and gastro-intestinal hormone levels change after a POSE procedure with an increased (as compared to typical) number of anchors placed.

Full description

This study will use the USGI Medical Incisionless Operating Platform (IOP) to determine the affects of placing more Suture Anchors per patient (as compared to the current practice) in Primary Obesity Surgery Endoluminal(POSE). USGI wants to see if placing more anchors (particularly in the distal body/antrum region) significantly impacts primary weight loss, satiety, and metabolic outcomes.

Enrollment

10 patients

Sex

All

Ages

21 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Has a BMI of >30 and <40
Male or female ≥21 yrs. of age and < 60 yrs. of age at time of enrollment
Patient has had no significant weight change (+/- 5% of total body weight) in last 6 months but has been able to lose significant weight in the past with diet and exercise.
Is a reasonable candidate for general anesthesia
Agrees not to have any additional weight loss interventional procedures or liposuction for at least 18 months following study enrollment and agrees not to take any prescription or over the counter weight loss medications for at least 1 year.
Physically and mentally able to comply with the visit schedule, ancillary testing, and behavior modification (diet and exercise) required for the study and agrees to study commitment requirements
Had successful completion of the pre-screening, nutritional and educational programs and psychological assessment supporting that the subject is an appropriate bariatric surgical candidate

Exclusion criteria

History of (or intra-operative evidence of) bariatric, gastric or esophageal surgery
Esophageal stricture or other anatomy and/or condition that could preclude passage of endolumenal instruments
Moderate to severe Gastro-esophageal reflux disease (GERD)
Known hiatal hernia >3cm by history or as determined by UGI exam or endoscopy
Known GI motility disorder or pancreatic insufficiency/disease
Intra-operative Exclusion: Active peptic ulcer or hiatal hernia >3cm
Pregnancy.
Present Corticosteroid Use
History of inflammatory disease of GI tract
Severe coagulopathies, hepatic insufficiency or cirrhosis
History or present use of insulin or insulin derivatives for treatment of diabetes
Had Type II Diabetes Mellitus (as defined by HgbA1c >6.0) for greater than 2 years at the time of enrollment
Uncontrolled Type II DM (HgbA1c >7.0 at screening)
Patient has quit smoking within last 6 months at time of enrollment or plans to quit smoking in the next year
Patient has a history of drug or alcohol abuse or actively abusing either
Patient is presently being treated with medication for depression, psychosis, or other mood or eating disorder
Non-ambulatory or has significant impairment of mobility
Works for, or is first degree relative of investigator, study institution, or support staff involved in the study.
Known hormonal or genetic cause for obesity
Participating in another clinical study
Patient is on medications known to impact GI motility or gut hormones that cannot be discontinued prior to nuclear testing
Have work hours, family obligations or transportation issues that could interfere with patient returning for all scheduled evaluations, tests and nutritional counseling.
Lives >60 kilometers from investigator site.
Patient is not able to provide written informed consent