Clinical trial NCT01771276: ULTIMATE Study for Weight Loss
Official title: Evaluating Impact of ULTIMATE Number of G-CATH EZ- Suture Anchors Placed Endoscopically on Motility, Metabolism, Satiety, and Weight Utilizing the Incisionless Operating Platform for the Treatment of Primary Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: POSE
Lead sponsor: USGI Medical
Sponsor class: INDUSTRY
First posted: 2013-01-18
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight Loss
timeFrame: 18 months
Secondary outcomes:
measure: Gastric emptying
timeFrame: Immediately Pre-procedure, & 2 & 6 months post procedure
Other outcomes:
measure: Satiety
timeFrame: Immediately Pre-procedure, & 2 & 6 months post procedure
measure: Peptide Measurements
timeFrame: Immediately Pre-procedure & 2 Months post procedure
Locations:
city: Barcelona
country: Spain
facility: Centro Medico Teknon
Study officials:
affiliation: Centro Medico Teknon
name: Jorge C Espinos, MD
role: PRINCIPAL_INVESTIGATOR
References: