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MOTIVATE Weight Loss Study (MOTIVATE)

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Using The IOP system from USGI to place suture anchors
Sponsored by
USGI Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Using POSE as a treatment for Obesity

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro Medico

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Continuous Horizontal row

Reduction in "ring" opening

Control Arm

Arm Description

Use the IOP system from USGI to install suture anchors running from the distal body into the proximal antrum

Use the IOP system from USGI to install suture anchors to reduce the "ring" opening to the antrum

Use the IOP system from USGI to install suture anchors in the Current V shape in distal body

Outcomes

Primary Outcome Measures

Weight Loss
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
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 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.

Full Information

First Posted
August 31, 2012
Last Updated
April 1, 2015
Sponsor
USGI Medical
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1. Study Identification

Unique Protocol Identification Number
NCT01679158
Brief Title
MOTIVATE Weight Loss Study
Acronym
MOTIVATE
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

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
USGI Medical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Using POSE as a treatment for Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous Horizontal row
Arm Type
Experimental
Arm Description
Use the IOP system from USGI to install suture anchors running from the distal body into the proximal antrum
Arm Title
Reduction in "ring" opening
Arm Type
Experimental
Arm Description
Use the IOP system from USGI to install suture anchors to reduce the "ring" opening to the antrum
Arm Title
Control Arm
Arm Type
Experimental
Arm Description
Use the IOP system from USGI to install suture anchors in the Current V shape in distal body
Intervention Type
Device
Intervention Name(s)
Using The IOP system from USGI to place suture anchors
Other Intervention Name(s)
The g-Cath EZ Suture Anchor Delivery Catheter
Intervention Description
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
Primary Outcome Measure Information:
Title
Weight Loss
Description
Each patient's weight will be measured and recorded on a monthly basis out to 18 months post procedure
Time Frame
Monthly post procedure out to 18 months
Secondary Outcome Measure Information:
Title
Fasting/Post-prandial Peptides
Description
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 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.
Time Frame
pre-procedure & 8 weeks post procedure
Other Pre-specified Outcome Measures:
Title
Gastric Emptying
Description
This test consists of determining the duration of a radioactive marker in a stomach, which is non-absorbable, and free of any food components.
Time Frame
Pre-procedure & 2 & 6 months post procedure
Title
Satiety Testing
Description
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.
Time Frame
Pre-procedure & 2 & 6 months post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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 endoluminal 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge C. Espinos, MD
Organizational Affiliation
Centro Medico Teknon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Medico
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08022
Country
Spain

12. IPD Sharing Statement

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