MOTIVATE Weight Loss Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by USGI Medical.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
USGI Medical
ClinicalTrials.gov Identifier:
NCT01679158
First received: August 31, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Obesity
Device: Using The IOP system from USGI to place suture anchors

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by USGI Medical:

Primary Outcome Measures:
  • Weight Loss [ Time Frame: Monthly post procedure out to 18 months ] [ Designated as safety issue: No ]
    Each patient's weight will be measured and recorded on a monthly basis out to 18 months post procedure


Secondary Outcome Measures:
  • Fasting/Post-prandial Peptides [ Time Frame: pre-procedure & 8 weeks post procedure ] [ Designated as safety issue: No ]
    1. Samples to be collected when fasting and 30, 60, 90, and 120 minutes after a standard meal (a meal consisting of 400 calories), The meal must be consumed within 10 minutes.. Serum collection tubes will be centrifuged immediately at 4°C for 10 minutes at 3600rpm and stored at -20°C
    2. Samples to be collected by ELISA are: C-peptide, serum insulin, glucose, PYY, GLP-1 (active), leptin, and GIP. Total ghrelin level to be analyzed by RIA.


Other Outcome Measures:
  • Gastric Emptying [ Time Frame: Pre-procedure & 2 & 6 months post procedure ] [ Designated as safety issue: No ]
    This test consists of determining the duration of a radioactive marker in a stomach, which is non-absorbable, and free of any food components.

  • Satiety Testing [ Time Frame: Pre-procedure & 2 & 6 months post procedure ] [ Designated as safety issue: No ]
    The subjects ingest a nutritional drink (Ensure) at a constant rate of 30 mL per minute, constantly filling the glass with a perfusion pump (Gemini PC-2, IMED, San Diego, CA). (The subjects are not conscious of the volume being ingested.) The subjects are instructed to maintain consumption at the fill rate. Participants take note of their sensation of satiety with a graphical classification scale, which combines verbal descriptors on a scale of 0 to 5 (0 = no symptoms, 1 = first sensation of fullness [threshold]; 2 = light, 3 = moderate, 4 = severe, and 5 = maximum fullness or unbearable). The participants are told to stop taking the food product when a score of 5 is obtained. The maximum consumption of volume of the nutritional drink is recorded.


Enrollment: 18
Study Start Date: February 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Continuous Horizontal row
Use the IOP system from USGI to install suture anchors running from the distal body into the proximal antrum
Device: Using The IOP system from USGI to place suture anchors

Sutures are placed in the distal body in one of three randomized techniques:

"A" = reduction in "ring" opening to antrum using plications "B" = continuous horizontal row, running from distal body into proximal antrum "C" = Control. Current V shape as Control

Other Name: The g-Cath EZ Suture Anchor Delivery Catheter
Experimental: Reduction in "ring" opening
Use the IOP system from USGI to install suture anchors to reduce the "ring" opening to the antrum
Device: Using The IOP system from USGI to place suture anchors

Sutures are placed in the distal body in one of three randomized techniques:

"A" = reduction in "ring" opening to antrum using plications "B" = continuous horizontal row, running from distal body into proximal antrum "C" = Control. Current V shape as Control

Other Name: The g-Cath EZ Suture Anchor Delivery Catheter
Experimental: Control Arm
Use the IOP system from USGI to install suture anchors in the Current V shape in distal body
Device: Using The IOP system from USGI to place suture anchors

Sutures are placed in the distal body in one of three randomized techniques:

"A" = reduction in "ring" opening to antrum using plications "B" = continuous horizontal row, running from distal body into proximal antrum "C" = Control. Current V shape as Control

Other Name: The g-Cath EZ Suture Anchor Delivery Catheter

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679158

Locations
Spain
Centro Medico
Barcelona, Catalonia, Spain, 08022
Sponsors and Collaborators
USGI Medical
Investigators
Principal Investigator: Jorge C. Espinos, MD Centro Medico Teknon
  More Information

No publications provided

Responsible Party: USGI Medical
ClinicalTrials.gov Identifier: NCT01679158     History of Changes
Other Study ID Numbers: TPR600
Study First Received: August 31, 2012
Last Updated: August 31, 2012
Health Authority: Spain: Directorate of Health Resources, Catalonian Dep't. of Health

Keywords provided by USGI Medical:
Using POSE as a treatment for Obesity

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014