ObesityGESNCT01823705
Gastric Electrical Stimulation (GES) for the Treatment of Obesity
A study testing Exilis Implantable Gastric Electrical Stimulation (GES) in people with Obesity, run by Medtronic Corporate Technologies and New Ventures at 4 sites in 2 countries.
Trial summary
The purpose of this feasibility study is to provide safety data on the implantable Exilis gastric electrical stimulation (GES) system, to individually adjust stimulation parameters to levels that are comfortable for implanted subjects during chronic daily treatment, and to collect data on acute gastrointestinal… Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- Obesity
- What is being tested?
- Exilis Implantable Gastric Electrical Stimulation (GES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 29 Mar 2013to 13 Jan 2017
- 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 21 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults ages 21-64 with BMI of 40-45 kg/m^2 or BMI 35-39.9 kg/m^2 with at least one obesity-related comorbidity, who have failed prior non-surgical weight loss attempts, and have been within 5% of their current weight for at least one year.
- If diabetic, subject has non-insulin-dependent type 2 diabetes mellitus diagnosed within the last 7 years, and has an HbA1c level less than 8%.
- If female and of child-bearing age, subject is not pregnant or lactating and is willing to use effective contraception for the duration of the study.
- Subject is willing and able to complete scheduled study visits, complete on-line lifestyle educational modules, and complete required procedures.
Who cannot join
- Subject has a history of medical, surgical, or psychiatric conditions that, in the opinion of the Investigators, would limit study participation or contraindicate implantation of the Exilis GES system. Examples includes cardiac abnormalities contraindicating surgical anesthesia, prior gastrointestinal surgery, gastrointestinal motility disorders, inflammatory bowel disease, a history of eating disorders, anticipated future need for magnetic resonance imaging, or allergies to food ingredients in study test meals.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Study site
Louisville, Kentucky, 40202
Study site
Nashville, Tennessee, 37232
Study site
Scottsdale, Arizona, 85258
About this study
The purpose of this feasibility study is to provide safety data on the implantable Exilis gastric electrical stimulation (GES) system, to individually adjust stimulation parameters to levels that are comfortable for implanted subjects during chronic daily treatment, and to collect data on acute gastrointestinal function and food intake responses to GES during in-clinic testing.
- Conditions
- Obesity
- Being tested
- Exilis Implantable Gastric Electrical Stimulation (GES)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exilis Implantable Gastric Electrical Stimulation (GES)Device
Also called Exilis Implantable Gastric Electrical Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Gastric Electrical Stimulation (GES) | Experimental | Gastric Electrical Stimulation (GES) therapy for the treatment of obesity. Receives: Device: Exilis Implantable Gastric Electrical Stimulation (GES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
First-in-human experience with the Exilis System, including initial clinical feasibility and safety data, as well as data on device performance (e.g., recharge durations and intervals) and use conditions (e.g., stimulation amplitudes, lead impedances).
Once adjudicated by the Adverse Events Advisory Committee (AEAC), all adverse events recorded during the study were tabulated and summarized by seriousness, intensity, and related. Device performance and use conditions where characterized by collecting data on amplitude settings and lead impedance recorded during device interrogations and conducted at each clinic visits. The data will be tabulated and summarized using descriptive statistics, but no hypotheses tests were pre-specified
Measured: Duration of study
To gain an understanding of what sensations, if any, subjects feel during GES treatment, and what level and type of sensations subjects find acceptable and comfortable during chronic daily treatment.
In-clinic sensory testing and telephone follow-up were collected during Amplitude Titration phase and will be summarized. No formal hypothesis testing were pre-specified. Fourt separate visits were conducted approximately weekly during the titration phase. The testing procedure was expected to be repeated twice during each visits; once in a fasted state and once in a fed state. Subjects were asked to rate exposure sensitive from 0 (none) to 5 (intense)
Measured: 4 weeks
Secondary outcomes (5)
Change in gastric emptying time across a pair of in-clinic measurements made with and without GES.
During the two GI function visits subjects completed the same set of acute tests on two separate days, once with GES On and once with GES Off. Treatment ordering was randomly assigned in a balanced fashion. Each testing visit was preceded by a one week GES Off washout period. The gastric emptying half time outcomes in the acute cross-over experiment will be analyzed using the repeated measures regression with fixed subject and test-day effects, with the model-based t-test for the difference in the marginal means of T1/2 across treatments being used for statistical inference.
Measured: Screening, Week 26 and Week 52
Change in whether GES delivered with the Exilis System suppresses post-meal gastric contractile activity
Antral motility index outcomes in the acute cross-over experiment were analyzed using the repeated measures regression with fixed subject and test-day effects. The model-based t-test for the difference in the marginal means of the MI values across treatments will be used for statistical inference.
Measured: 8 and 10 weeks
Change in post-meal plasma glucose and insulin concentrations
Blood samples were collected in conjunction with the gastric emptying test meals to explore whether GES alters plasma levels of gut peptides involved in regulating food intake and body weight, including GLP-1, PP, and CCK.
Measured: Baseline and 6 months
Changes in coloric intake during a standardized ad libitum solid meal consumed in a controlled setting
During the GI function tests in the acute-cross over experiments subjects were fed a macaroni and cheese meal in a controlled setting. the meal was given at each GI function visit once with GES On and once with GES Off. The caloric intake was measured during the visit to determine whether the GES On would reduce meal intake.
Measured: 8 and 10 weeks
Change in physiological parameters, medication usage, and psychometric assessment scores that occur during chronic daily GES treatment with the Exilis System.
The values of physiological measures, psychometric assessment questionnaire scores and changes in these values from the Screening visit baseline will be summarized by visit using descriptive statistics. Medications will be categorized by their primary indications for use, and the proportion of subjects taking medications in each category and the mean number of medications in each category per subject will be calculated at each visit and plotted over time. No formal hypothesis testing will be conducted.
Measured: Study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study start29 Mar 2013
- Primary completion13 Jan 2017
- Study completion13 Jan 2017
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Corporate Technologies and New Ventures
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823705
- Sponsor's protocol ID
- Exilis-1
- Acronym
- GES
- Status last verified
- Sep 2018
- First submitted
- 26 Mar 2013
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Electrical Stimulation (GES) for the Treatment of Obesity
- ClinicalTrials.gov ID
- NCT01823705
- Acronym / sponsor ID
- GES / Exilis-1
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Medtronic Corporate Technologies and New VenturesIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2013 (actual)
- Primary completion
- 13 Jan 2017 (actual)
- Study completion
- 13 Jan 2017 (actual)
- First posted
- 4 Apr 2013 (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 feasibility study is to provide safety data on the implantable Exilis gastric electrical stimulation (GES) system, to individually adjust stimulation parameters to levels that are comfortable for implanted subjects during chronic daily treatment, and to collect data on acute gastrointestinal function and food intake responses to GES during in-clinic testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastric Electrical Stimulation (GES) | Experimental | Device: Exilis Implantable Gastric Electrical Stimulation (GES)Gastric Electrical Stimulation (GES) therapy for the treatment of obesity. |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults ages 21-64 with BMI of 40-45 kg/m^2 or BMI 35-39.9 kg/m^2 with at least one obesity-related comorbidity, who have failed prior non-surgical weight loss attempts, and have been within 5% of their current weight for at least one year.
- If diabetic, subject has non-insulin-dependent type 2 diabetes mellitus diagnosed within the last 7 years, and has an HbA1c level less than 8%.
- If female and of child-bearing age, subject is not pregnant or lactating and is willing to use effective contraception for the duration of the study.
- Subject is willing and able to complete scheduled study visits, complete on-line lifestyle educational modules, and complete required procedures.
Key exclusion criteria (1 listed)
- Subject has a history of medical, surgical, or psychiatric conditions that, in the opinion of the Investigators, would limit study participation or contraindicate implantation of the Exilis GES system. Examples includes cardiac abnormalities contraindicating surgical anesthesia, prior gastrointestinal surgery, gastrointestinal motility disorders, inflammatory bowel disease, a history of eating disorders, anticipated future need for magnetic resonance imaging, or allergies to food ingredients in study test meals.
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 |
|---|---|---|
| Exilis Implantable Gastric Electrical Stimulation (GES)Also: Exilis Implantable Gastric Electrical Stimulation | Device | Gastric Electrical Stimulation (GES) |
Primary outcome
First-in-human experience with the Exilis System, including initial clinical feasibility and safety data, as well as data on device performance (e.g., recharge durations and intervals) and use conditions (e.g., stimulation amplitudes, lead impedances).
Time frame: Duration of study
Once adjudicated by the Adverse Events Advisory Committee (AEAC), all adverse events recorded during the study were tabulated and summarized by seriousness, intensity, and related. Device performance and use conditions where characterized by collecting data on amplitude settings and lead impedance recorded during device interrogations and conducted at each clinic visits. The data will be tabulated and summarized using descriptive statistics, but no hypotheses tests were pre-specified
To gain an understanding of what sensations, if any, subjects feel during GES treatment, and what level and type of sensations subjects find acceptable and comfortable during chronic daily treatment.
Time frame: 4 weeks
In-clinic sensory testing and telephone follow-up were collected during Amplitude Titration phase and will be summarized. No formal hypothesis testing were pre-specified. Fourt separate visits were conducted approximately weekly during the titration phase. The testing procedure was expected to be repeated twice during each visits; once in a fasted state and once in a fed state. Subjects were asked to rate exposure sensitive from 0 (none) to 5 (intense)
5 secondary outcomes
Change in gastric emptying time across a pair of in-clinic measurements made with and without GES.
Time frame: Screening, Week 26 and Week 52
Change in whether GES delivered with the Exilis System suppresses post-meal gastric contractile activity
Time frame: 8 and 10 weeks
Change in post-meal plasma glucose and insulin concentrations
Time frame: Baseline and 6 months
Changes in coloric intake during a standardized ad libitum solid meal consumed in a controlled setting
Time frame: 8 and 10 weeks
Change in physiological parameters, medication usage, and psychometric assessment scores that occur during chronic daily GES treatment with the Exilis System.
Time frame: Study duration
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 2 Oct 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exilis Implantable Gastric Electrical Stimulation (GES) in people with Obesity, run by Medtronic Corporate Technologies and New Ventures at 4 sites in 2 countries.
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 4 inclusion and 1 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 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Netherlands. 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. 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?
First-in-human experience with the Exilis System, including initial clinical feasibility and safety data, as well as data on device performance (e.g., recharge durations and intervals) and use conditions (e.g., stimulation amplitudes, lead impedances). (time frame: Duration of study). The study lists 2 primary outcomes in all. 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 2 Oct 2018.