THE ENLIGHTEN STUDY

• Sponsor: Allurion Technologies (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT03261453
• Collaborator: (none)
• Enrollment: 400
• Locations: 12
• Arms: 2
• Anticipated Duration (Months): 14.9
• Patients Per Site: 33.3
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Overweight	Device: Active Elipse Device; Device: Elipse Sham Device	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Feb 1, 2018
• Anticipated Primary Completion Date: May 1, 2019
• Anticipated Study Completion Date: May 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Patients randomized to treatment will receive the Elipse device.	Device: Active Elipse Device; Intervention Device; Other Names: Elipse Gastric Balloon System (active)
Sham Comparator: Control Patients randomized to the control arm will receive the sham device.	Device: Elipse Sham Device; Control Device; Other Names: Elipse Gastric Balloon System (control)

Outcome Measures

Primary Outcome Measures

1. Co-Primary Effectiveness Endpoint: Total Body Weight Loss (TBWL) Comparison Between Treatment and Control Group at 16 weeks [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%.

2. Co-Primary Effectiveness Endpoint 2: Percent of Total Body Weight Loss (TBWL) Comparison Between Treatment and Control group [16 weeks]

   An inferential test of whether the Treatment Group mean %TBWL is significantly greater than Control Group mean % TBWL at 16 weeks

3. Primary Safety Endpoint: Incidence of overall procedure or device related Serious Adverse Events [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age ≥ 22 years and ≤ 65 years of age

2. BMI ≥30 kg/m2 and ≤ 40 kg/m2

3. Have signed study specific Informed Consent Form

4. Willing to comply with study requirements, including follow-up visits

5. Documented negative pregnancy test in women of childbearing potential.

6. 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).

7. Fully ambulatory without any severe chronic orthopedic disease that requires reliance on crutches, walkers or a wheelchair that could preclude exercise during the study.

8. 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.

Exclusion Criteria:

1. Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease

2. Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer

3. Previous bariatric or gastric surgery or likely to undergo during study

4. Use of an intragastric device prior to this study

5. Chronic pancreatitis or acute pancreatitis within 12 months of enrollment

6. History of or current small bowel obstructions

7. 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)

8. Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous, scleroderma) or immunocompromised

9. History of genetic or endocrine causes of obesity not adequately controlled by medication

10. 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

11. Insulin-dependent diabetes (either Type 1 or Type 2)

12. Significant acute and/or chronic infections of any kind

13. Severe coagulopathy, hepatic insufficiency or cirrhosis

14. 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

15. 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)

1. History of pulmonary embolism

2. Has cardiac pacemaker or other electric implantable device

3. Anemia defined as either:

4. Hgb < 11 for females, <12 for males

5. Abnormal red cell indices and iron deficiency

6. Smoking cessation within 3 months of enrollment or plans to quit smoking during the study

7. Documented total body weight loss of ≥ 5% anytime 6 months preceding enrollment

8. Residing in a location without ready access to study site medical resources

9. Inability to walk 200 yards without assistance

10. Eating disorders including night eating syndrome (NES), bulimia, or binge eating disorder

11. Unwilling to refrain from any reconstructive and/or cosmetic surgery that may affect body weight during the study such as mammoplasty and lipoplasty

12. Current or history of illicit drug use or excessive alcohol use

13. 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).

14. 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.

15. Patient is not of sufficient medical health as determined by the Investigator to participate in the study.

16. Employees/family members of Allurion Technologies or any of its affiliates or contractors

17. 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

18. An immediate family member (by marriage or blood relationship) of another subject already enrolled in the study

19. Positive breath test for H. Pylori

20. History of or current inflammatory bowel disease (e.g. Crohn's disease, Ulcerative Colitis)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Honor Health	Scottsdale	Arizona	United States	85258
2	University of Colorado, Anschutz Health and Wellness Center	Aurora	Colorado	United States	80045
3	Bariatric Institute of Greater Chicago	Bolingbrook	Illinois	United States	60440
4	Surgical Specialists of Louisiana	Metairie	Louisiana	United States	70001
5	Holyoke Medical Center	Holyoke	Massachusetts	United States	01002
6	Weill Cornell Medicine, Division of Endocrinology, Diabetes and Metabolism	New York	New York	United States	10065
7	University of Pennsylvania Medical Center (UPMC)	Pittsburgh	Pennsylvania	United States	15213
8	CHI Metabolic and Bariatric Care	Chattanooga	Tennessee	United States	37421
9	MidSouth Bariatrics	Memphis	Tennessee	United States	38120
10	Vanderbilt Center for Surgical Weight Loss	Nashville	Tennessee	United States	37204
11	UT Physicians Minimally Invasive Surgeons of Texas (UTMIST)	Bellaire	Texas	United States	77401
12	Charlottesville Medical Research Center	Charlottesville	Virginia	United States	22291

Sponsors and Collaborators

• Allurion Technologies

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allurion Technologies
• ClinicalTrials.gov Identifier: NCT03261453
• Other Study ID Numbers: TRL-1000-0002
• First Posted: Aug 25, 2017
• Last Update Posted: Aug 9, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Overweight

Study Results

No Results Posted as of Aug 9, 2018