ObesitySHAPENCT00200083
Study of Weight Loss Using Gastric Stimulation in Obese Patients
A study testing Transcend II Model 8848 in people with Obesity and Morbid Obesity, run by MedtronicNeuro at 8 sites in United States.
Trial summary
The purpose of this study is to test the effect of an implanted device that stimulates the stomach to help obese patients lose weight. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Morbid Obesity
- What is being tested?
- Transcend II Model 8848
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 8 sitesUnited States
- Study dates
- May 2004to Jan 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 65 years of age at time of screening
- BMI of 35 to 55 kg/m2 at time of screening
- Patients with a reported history of five years of obesity (BMI > 30 kg/m2)
Who cannot join
- Patients who are excluded by the screening algorithm
- Patients scoring 29 or higher on the Binge Eating Scale Questionnaire
- Patients taking any weight loss medication or other drugs that can affect body weight
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Contact Medtronic for specific site information
Boston, Massachusetts, 02111
Contact Medtronic for specific site information
Chicago, Illinois, 60611
Contact Medtronic for specfici site information
Gainsville, Florida, 32611
Contact Medtronic for specific site information
Minneapolis, Minnesota, 55416
Contact Medtronic for specific site information
New York, New York, 10032
Contact Medtronic for specific site information
Philadelphia, Pennsylvania, 19140
Contact Medtronic for specific site information
St Louis, Missouri, 60611
Contact Medtronic for specific site information
Washington D.C., District of Columbia, 20037
About this study
Official title: SHAPE: Screened Health Assessment & Pacer Evaluation
The purpose of this study is to test the effect of an implanted device that stimulates the stomach to help obese patients lose weight.
Read the detailed description
The purpose of this study was to evaluate efficacy and safety of the IGS system in a population of patients with a BMI between 35 and 55 kg/m2.
SHAPE was a randomized, placebo-controlled, double-blind, multi-center pivotal study in which all subjects were implanted with the IGS system.
- Conditions
- Obesity, Morbid Obesity
- Being tested
- Transcend II Model 8848
- Keywords
- Obesity, Morbid Obesity, SHAPE, IGS, Implantable Gastric Stimulator
- Medical subject headings
- Obesity, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcend II Model 8848Device
All subjects will be implanted with the IGS device and then randomized to "on" or "off" for 12 months. After 12 months all subjects will be turned "on" through 24 month follow up.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | All subjects enrolled will be implanted with an IGS system. The active group are those randomized to "on" and will receive active stimulation for 12 months. Receives: Device: Transcend II Model 8848 |
| B | Placebo comparator | All subjects enrolled will be implanted with an IGS system. The placebo group are those randomized to "off" and will receive no stimulation for 12 months. Receives: Device: Transcend II Model 8848 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent excess weight loss (%EWL) from baseline after 12 months from randomization.
Measured: Baseline, 12 months
Secondary outcomes (7)
Percent excess weight loss (% EWL) from baseline at each study visit
Measured: Baseline and each study visit
Change from baseline in levels of satiety and appetite at each study visit.
Measured: Baseline and each study visit
Percentage change in body weight and BMI from baseline at each study visit
Measured: Baseline and each study visit
Proportion of subjects who attain ≥ 20% EWL from baseline after 12 months from randomization
Measured: Baseline and 12 months.
Proportion of subjects who lose ≥ 5% in body weight from baseline through Month 9, and maintain the weight loss for at least 3 months (i.e., through 12 months from randomization)
Measured: Baseline and each study visit.
Time to loss of weight maintenance or "relapse of weight loss"
Measured: Baseline and each study visit
Incidence of adverse events, Incidence of device complications, Change in blood chemistry and hematology laboratory assessments
Measured: During the course of the study until termination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMay 2004
- Primary completionSep 2005
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Obesity Study Team Obesity Study Team, Study chair, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200083
- Sponsor's protocol ID
- 95-2002-015
- Acronym
- SHAPE
- Status last verified
- Mar 2015
- First submitted
- 12 Sep 2005
- Last updated
- 27 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SHAPE: Screened Health Assessment & Pacer Evaluation
- ClinicalTrials.gov ID
- NCT00200083
- Acronym / sponsor ID
- SHAPE / 95-2002-015
- Conditions
- Obesity, Morbid Obesity
- Keywords
- Obesity, Morbid Obesity, SHAPE, IGS, Implantable Gastric Stimulator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Sep 2005 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the effect of an implanted device that stimulates the stomach to help obese patients lose weight.
Detailed description
The purpose of this study was to evaluate efficacy and safety of the IGS system in a population of patients with a BMI between 35 and 55 kg/m2.
SHAPE was a randomized, placebo-controlled, double-blind, multi-center pivotal study in which all subjects were implanted with the IGS system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Device: Transcend II Model 8848All subjects enrolled will be implanted with an IGS system. The active group are those randomized to "on" and will receive active stimulation for 12 months. |
| B | Placebo comparator | Device: Transcend II Model 8848All subjects enrolled will be implanted with an IGS system. The placebo group are those randomized to "off" and will receive no stimulation for 12 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 65 years of age at time of screening
- BMI of 35 to 55 kg/m2 at time of screening
- Patients with a reported history of five years of obesity (BMI > 30 kg/m2)
Key exclusion criteria (3 listed)
- Patients who are excluded by the screening algorithm
- Patients scoring 29 or higher on the Binge Eating Scale Questionnaire
- Patients taking any weight loss medication or other drugs that can affect body weight
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcend II Model 8848All subjects will be implanted with the IGS device and then randomized to "on" or "off" for 12 months. After 12 months all subjects will be turned "on" through 24 month follow up. | Device | A, B |
Primary outcome
Percent excess weight loss (%EWL) from baseline after 12 months from randomization.
Time frame: Baseline, 12 months
7 secondary outcomes
Percent excess weight loss (% EWL) from baseline at each study visit
Time frame: Baseline and each study visit
Change from baseline in levels of satiety and appetite at each study visit.
Time frame: Baseline and each study visit
Percentage change in body weight and BMI from baseline at each study visit
Time frame: Baseline and each study visit
Proportion of subjects who attain ≥ 20% EWL from baseline after 12 months from randomization
Time frame: Baseline and 12 months.
Proportion of subjects who lose ≥ 5% in body weight from baseline through Month 9, and maintain the weight loss for at least 3 months (i.e., through 12 months from randomization)
Time frame: Baseline and each study visit.
Time to loss of weight maintenance or "relapse of weight loss"
Time frame: Baseline and each study visit
Incidence of adverse events, Incidence of device complications, Change in blood chemistry and hematology laboratory assessments
Time frame: During the course of the study until termination.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Obesity Study Team Obesity Study Team study chair
Medtronic
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcend II Model 8848 in people with Obesity and Morbid Obesity, run by MedtronicNeuro at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent excess weight loss (%EWL) from baseline after 12 months from randomization. (time frame: Baseline, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2015.