Clinical trial NCT01679158: MOTIVATE Weight Loss Study
Official title: Evaluating MOTIlity, Hormonal Impact, Satiety, and Weight Changes With VArying Procedural TEchniques Utilizing the Incisionless Operating Platform for the Treatment of Primary Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Using POSE as a treatment for Obesity
Lead sponsor: USGI Medical
Sponsor class: INDUSTRY
First posted: 2012-09-05
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the impact of minor variations in Incisionless Operating Platform (IOP)procedural techniques on gastric emptying, hormone levels, satiety, and weight loss in the treatment of primary obesity. It will confirm, in an open prospective study, the action mechanisms for the "POSE" endoscopic treatment technique for obesity, and it will help determine if they are maintained at least 6 months following the procedure. Durability of weight loss will be tracked through post-POSE visits up to 18 months following the procedure.


Eligibility criteria: Inclusion Criteria:

1. Has a BMI of \>30 and \<40
2. Male or female ≥21 yrs. of age and \< 60 yrs. of age at time of enrollment
3. 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.
4. Is a reasonable candidate for general anesthesia
5. 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.
6. 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
7. 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:

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

Primary outcomes:
measure: Weight Loss
timeFrame: Monthly post procedure out to 18 months
Secondary outcomes:
measure: Fasting/Post-prandial Peptides
timeFrame: pre-procedure & 8 weeks post procedure
Other outcomes:
measure: Gastric Emptying
timeFrame: Pre-procedure & 2 & 6 months post procedure
measure: Satiety Testing
timeFrame: Pre-procedure & 2 & 6 months post procedure
Locations:
city: Barcelona
country: Spain
facility: Centro Medico
state: Catalonia
Study officials:
affiliation: Centro Medico Teknon
name: Jorge C. Espinos, MD
role: PRINCIPAL_INVESTIGATOR
References: