THE ENLIGHTEN STUDY

NCT03261453 | Completed DMC FDA Device

• 1 other identifier: TRL-1000-0002
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 12

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.

Conditions

Obesity; Overweight

Outcome Measures

Primary Outcomes (3)

• 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%.

  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

  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.

  24 weeks

Study Arms (2)

Treatment

EXPERIMENTAL

Patients randomized to treatment will receive the Elipse device.

Device: Active Elipse Device

Control

SHAM COMPARATOR

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

Device: Elipse Sham Device

Interventions

Active Elipse Device DEVICE

Intervention Device

Also known as: Elipse Gastric Balloon System (active)

Treatment

Elipse Sham Device DEVICE

Control Device

Also known as: Elipse Gastric Balloon System (control)

Control

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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:

Sponsors & Collaborators

• Allurion Technologies: lead

Study Sites (12)

Honor Health

Scottsdale, Arizona, 85258, United States

Location

University of Colorado, Anschutz Health and Wellness Center

Aurora, Colorado, 80045, United States

Location

Bariatric Institute of Greater Chicago

Bolingbrook, Illinois, 60440, United States

Location

Surgical Specialists of Louisiana

Metairie, Louisiana, 70001, United States

Location

Holyoke Medical Center

Holyoke, Massachusetts, 01002, United States

Location

Weill Cornell Medicine, Division of Endocrinology, Diabetes and Metabolism

New York, New York, 10065, United States

Location

University of Pennsylvania Medical Center (UPMC)

Pittsburgh, Pennsylvania, 15213, United States

Location

CHI Metabolic and Bariatric Care

Chattanooga, Tennessee, 37421, United States

Location

MidSouth Bariatrics

Memphis, Tennessee, 38120, United States

Location

Vanderbilt Center for Surgical Weight Loss

Nashville, Tennessee, 37204, United States

Location

UT Physicians Minimally Invasive Surgeons of Texas (UTMIST)

Bellaire, Texas, 77401, United States

Location

Charlottesville Medical Research Center

Charlottesville, Virginia, 22291, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: August 25, 2017
• Study Start: February 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: February 2, 2024

Record last verified: 2024-01

Locations

US (12)