THE ENLIGHTEN STUDY

NCT ID: NCT03261453

Last Updated: 2024-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2019-05-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Treatment

Patients randomized to treatment will receive the Elipse device.

Group Type: EXPERIMENTAL

Active Elipse Device

Intervention Type: DEVICE

Intervention Device

Control

Patients randomized to the control arm will receive the sham device.

Group Type: SHAM_COMPARATOR

Elipse Sham Device

Intervention Type: DEVICE

Control Device

Interventions

Active Elipse Device

Intervention Device

Intervention Type: DEVICE

Elipse Sham Device

Control Device

Intervention Type: DEVICE

Other Intervention Names

Elipse Gastric Balloon System (active); Elipse Gastric Balloon System (control)

Eligibility Criteria

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)

16. History of pulmonary embolism

17. Has cardiac pacemaker or other electric implantable device

18. Anemia defined as either:

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

2. Abnormal red cell indices and iron deficiency

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

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

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

22. Inability to walk 200 yards without assistance

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

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

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

26. 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).

27. 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.

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

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

30. 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

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

32. Positive breath test for H. Pylori

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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allurion Technologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Honor Health

Scottsdale, Arizona, United States

University of Colorado, Anschutz Health and Wellness Center

Aurora, Colorado, United States

Bariatric Institute of Greater Chicago

Bolingbrook, Illinois, United States

Surgical Specialists of Louisiana

Metairie, Louisiana, United States

Holyoke Medical Center

Holyoke, Massachusetts, United States

Weill Cornell Medicine, Division of Endocrinology, Diabetes and Metabolism

New York, New York, United States

University of Pennsylvania Medical Center (UPMC)

Pittsburgh, Pennsylvania, United States

CHI Metabolic and Bariatric Care

Chattanooga, Tennessee, United States

MidSouth Bariatrics

Memphis, Tennessee, United States

Vanderbilt Center for Surgical Weight Loss

Nashville, Tennessee, United States

UT Physicians Minimally Invasive Surgeons of Texas (UTMIST)

Bellaire, Texas, United States

Charlottesville Medical Research Center

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

TRL-1000-0002

Identifier Type: -

Identifier Source: org_study_id