ObesityNCT03261453
THE ENLIGHTEN STUDY
A study testing Active Elipse Device in people with Obesity and Overweight, run by Allurion Technologies at 12 sites in United States.
Trial summary
The primary objective of this study is to demonstrate the safety and efficacy of the Elipse Gastric Balloon System for the treatment of obese adults. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Active Elipse Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 12 sitesUnited States
- Study dates
- 1 Feb 2018to 1 May 2019
- 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 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 22 years and ≤ 65 years of age
- BMI ≥30 kg/m2 and ≤ 40 kg/m2
- Have signed study specific Informed Consent Form
- Willing to comply with study requirements, including follow-up visits
- Documented negative pregnancy test in women of childbearing potential.
- Women of childbearing potential not intending to become pregnant for the duration of study participation. (Note: Women of childbearing potential must not be nursing at the time of treatment).
- Fully ambulatory without any severe chronic orthopedic disease that requires reliance on crutches, walkers or a wheelchair that could preclude exercise during the study.
- Confirmed unsuccessful attempts at more conservative weight reduction alternatives, such as supervised diet, exercise and behavior modification programs attempted within the 24 months preceding enrollment.
Who cannot join
- Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease
- Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer
- Previous bariatric or gastric surgery or likely to undergo during study
- Use of an intragastric device prior to this study
- Chronic pancreatitis or acute pancreatitis within 12 months of enrollment
- History of or current small bowel obstructions
Show all 37Show fewer
- History of abdominal and/or pelvic surgery EXCLUDING only ONE of the following surgeries that was performed at least 12 months prior to study enrollment: cesarean section, diagnostic laparoscopy, laparoscopic appendectomy, laparoscopic cholecystectomy. (For example: if a patient has had 2 cesarean sections, or one cesarean section and a laparoscopic appendectomy, she would be excluded. If a patient had one cesarean section, she may be included)
- Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous, scleroderma) or immunocompromised
- History of genetic or endocrine causes of obesity not adequately controlled by medication
- History of/or signs and/or symptoms of/or radiographic evidence of esophageal, gastric, or duodenal disease including but not limited to hiatal hernias greater than or equal to 2 centimeter (cm), paraesophageal hernias, inflammatory diseases, cancer, varices, diverticula, gastroparesis, ulcers, stricture/stenosis, achalasia and esophagitis
- Insulin-dependent diabetes (either Type 1 or Type 2)
- Significant acute and/or chronic infections of any kind
- Severe coagulopathy, hepatic insufficiency or cirrhosis
- Unable or unwilling to discontinue use of aspirin and/or non-steroidal anti-inflammatory agents (NSAIDs) at least 14 days prior to Elipse Deployment and continuing for 14 days after Elipse excretion
- Currently taking the following medications (within 30 days prior to enrollment) and/or there is a need or anticipated need for these medications during the study:
- Excluded Medications:
- Systemic corticosteroids Anticoagulant therapy (e.g. warafin, dabigatran) or anti-platelet therapy) Immunosuppressive therapy (e.g. azathioprine, cyclosporine) Prescription or over the counter weight loss medication(s) Medications known to cause significant weight gain or weight loss Narcotics, opiates or benzodiazepines Insulin for treatment of diabetes Anti-seizure therapy (e.g. clonazepam, phenytoin) Anti-arrhythmics (e.g. amidarone)
- History of pulmonary embolism
- Has cardiac pacemaker or other electric implantable device
- Anemia defined as either:
- Hgb < 11 for females, <12 for males
- Abnormal red cell indices and iron deficiency
- Smoking cessation within 3 months of enrollment or plans to quit smoking during the study
- Documented total body weight loss of ≥ 5% anytime 6 months preceding enrollment
- Residing in a location without ready access to study site medical resources
- Inability to walk 200 yards without assistance
- Eating disorders including night eating syndrome (NES), bulimia, or binge eating disorder
- Unwilling to refrain from any reconstructive and/or cosmetic surgery that may affect body weight during the study such as mammoplasty and lipoplasty
- Current or history of illicit drug use or excessive alcohol use
- Enrolled in another investigational study that has not completed the required primary endpoint follow-up period (Note: Subjects involved in a long-term surveillance phase of another study are eligible for enrollment in this study).
- Any conditions that, in the opinion of the investigator, may render the subject unable to complete the study with a likely fatal outcome, or lead to difficulties for subject compliance with study requirements, or could confound study data.
- Patient is not of sufficient medical health as determined by the Investigator to participate in the study.
- Employees/family members of Allurion Technologies or any of its affiliates or contractors
- Immediate employees/family members of the Investigator, sub-Investigators, or their medical office or practice, or surgical, bariatric or hospital organizations at which study procedures may be performed
- An immediate family member (by marriage or blood relationship) of another subject already enrolled in the study
- Positive breath test for H. Pylori
- History of or current inflammatory bowel disease (e.g. Crohn's disease, Ulcerative Colitis)
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Colorado, Anschutz Health and Wellness Center
Aurora, Colorado, 80045
UT Physicians Minimally Invasive Surgeons of Texas (UTMIST)
Bellaire, Texas, 77401
Bariatric Institute of Greater Chicago
Bolingbrook, Illinois, 60440
Charlottesville Medical Research Center
Charlottesville, Virginia, 22291
CHI Metabolic and Bariatric Care
Chattanooga, Tennessee, 37421
Holyoke Medical Center
Holyoke, Massachusetts, 01002
MidSouth Bariatrics
Memphis, Tennessee, 38120
Surgical Specialists of Louisiana
Metairie, Louisiana, 70001
Vanderbilt Center for Surgical Weight Loss
Nashville, Tennessee, 37204
Weill Cornell Medicine, Division of Endocrinology, Diabetes and Metabolism
New York, New York, 10065
University of Pennsylvania Medical Center (UPMC)
Pittsburgh, Pennsylvania, 15213
Honor Health
Scottsdale, Arizona, 85258
About this study
Official title: A Randomized, Multi-Center, Phased, Pivotal Safety and Efficacy Study Comparing the Elipse™ Gastric Balloon System vs. Sham for the Treatment of Obese Adults
The primary objective of this study is to demonstrate the safety and efficacy of the Elipse Gastric Balloon System for the treatment of obese adults.
Read the detailed description
This is a prospective, double-blinded, randomized, two-phase study to be conducted in a planned 400 obese individuals drawn from up to 15 sites. The treatment duration of the study is 48 weeks.
- Conditions
- Obesity, Overweight
- Being tested
- Active Elipse Device, Elipse Sham Device
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Elipse DeviceDevice
Also called Elipse Gastric Balloon System (active)
Intervention Device
Elipse Sham DeviceDevice
Also called Elipse Gastric Balloon System (control)
Control Device
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients randomized to treatment will receive the Elipse device. Receives: Device: Active Elipse Device |
| Control | Sham comparator | Patients randomized to the control arm will receive the sham device. Receives: Device: Elipse Sham Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-Primary Effectiveness Endpoint: Total Body Weight Loss (TBWL) Comparison Between Treatment and Control Group at 16 weeks
An inferential test of whether the Treatment Group Responder Rate (RR) dichotomized at 5% TBWL at 16 weeks is significantly greater than 35%.
Measured: 16 weeks
Co-Primary Effectiveness Endpoint 2: Percent of Total Body Weight Loss (TBWL) Comparison Between Treatment and Control group
An inferential test of whether the Treatment Group mean %TBWL is significantly greater than Control Group mean % TBWL at 16 weeks
Measured: 16 weeks
Primary Safety Endpoint: Incidence of overall procedure or device related Serious Adverse Events
The primary safety endpoint of this clinical investigation is the overall incidence of procedure- or device-related Serious Adverse Events through 24 weeks.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start1 Feb 2018
- Primary completion1 May 2019
- Study completion1 May 2019
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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allurion Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261453
- Sponsor's protocol ID
- TRL-1000-0002
- Status last verified
- Jan 2024
- First submitted
- 3 May 2017
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-Center, Phased, Pivotal Safety and Efficacy Study Comparing the Elipse™ Gastric Balloon System vs. Sham for the Treatment of Obese Adults
- ClinicalTrials.gov ID
- NCT03261453
- Acronym / sponsor ID
- TRL-1000-0002
- Conditions
- Obesity, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Allurion TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 25 Aug 2017 (actual)
- 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 primary objective of this study is to demonstrate the safety and efficacy of the Elipse Gastric Balloon System for the treatment of obese adults.
Detailed description
This is a prospective, double-blinded, randomized, two-phase study to be conducted in a planned 400 obese individuals drawn from up to 15 sites. The treatment duration of the study is 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Active Elipse DevicePatients randomized to treatment will receive the Elipse device. |
| Control | Sham comparator | Device: Elipse Sham DevicePatients randomized to the control arm will receive the sham device. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 22 years and ≤ 65 years of age
- BMI ≥30 kg/m2 and ≤ 40 kg/m2
- Have signed study specific Informed Consent Form
- Willing to comply with study requirements, including follow-up visits
- Documented negative pregnancy test in women of childbearing potential.
Key exclusion criteria (37 listed)
- Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease
- Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer
- Previous bariatric or gastric surgery or likely to undergo during study
- Use of an intragastric device prior to this study
- Chronic pancreatitis or acute pancreatitis within 12 months of enrollment
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 |
|---|---|---|
| Active Elipse DeviceAlso: Elipse Gastric Balloon System (active)Intervention Device | Device | Treatment |
| Elipse Sham DeviceAlso: Elipse Gastric Balloon System (control)Control Device | Device | Control |
Primary outcome
Co-Primary Effectiveness Endpoint: Total Body Weight Loss (TBWL) Comparison Between Treatment and Control Group at 16 weeks
Time frame: 16 weeks
An inferential test of whether the Treatment Group Responder Rate (RR) dichotomized at 5% TBWL at 16 weeks is significantly greater than 35%.
Co-Primary Effectiveness Endpoint 2: Percent of Total Body Weight Loss (TBWL) Comparison Between Treatment and Control group
Time frame: 16 weeks
An inferential test of whether the Treatment Group mean %TBWL is significantly greater than Control Group mean % TBWL at 16 weeks
Primary Safety Endpoint: Incidence of overall procedure or device related Serious Adverse Events
Time frame: 24 weeks
The primary safety endpoint of this clinical investigation is the overall incidence of procedure- or device-related Serious Adverse Events through 24 weeks.
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 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Elipse Device in people with Obesity and Overweight, run by Allurion Technologies at 12 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 8 inclusion and 37 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 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Co-Primary Effectiveness Endpoint: Total Body Weight Loss (TBWL) Comparison Between Treatment and Control Group at 16 weeks (time frame: 16 weeks). The study lists 3 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 Feb 2024; AzTrials last refreshed its copy on 27 Oct 2026.