Status:
UNKNOWN
Pilot Trial of the Elipse™ Intragastric Balloon System for the Treatment of Overweight and Obese Individuals
Lead Sponsor:
Allurion Technologies
Conditions:
Obesity
Overweight
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
This is a prospective, non-randomized, open trial to be conducted in overweight and obese individuals. The primary objective is to evaluate the safety of the Elipse™ Intragastric Balloon System for th...
Eligibility Criteria
Inclusion
- Patient, female or male, 18 to 64 years of age.
- Patient must be able to understand and be willing to sign an IC document.
- Patient must be willing to participate in all aspects of the trial for the duration of the trial.
- Patient must be motivated to lose weight and have realistic expectations.
- Patient must complete the screening requirement to complete one week of Daily Eating Diaries and Daily Weight Logs.
- Patient must pass the Screening Behavioral Interview.
- Patient must understand that even though they undergo the Elipse™ Treatment, they must follow the physician guidelines for eating behaviors and lifestyle modifications for weight loss.
- Patient has a BMI of ≥ 27.0.
- Females must be willing to use contraception throughout the course of the trial until they exit.
- Patients must have a primary care physician that follows them for any co-morbid conditions.
- Patients must live within 160 kilometers of the trial site and not plan to move out of the vicinity for the trial duration.
- Patients must be fully ambulatory without any chronic orthopedic disease or reliance on crutches, walkers or a wheelchair that could preclude exercise during the trial.
- Patient must have a stable home environment that is supportive of the patient's efforts to lose weight.
- If Patient is an ex-smoker, they must be an ex-smoker for more than a year.
- Patient agrees to refrain from any reconstructive and/or cosmetic surgery that may affect body weight during the study such as mammoplasty and lipoplasty.
Exclusion
- Patient has symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
- Patient has pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.
- Female subject who is pregnant (i.e., has a positive urine or blood pregnancy test prior to surgery), is suspected to be pregnant, is lactating or is of childbearing potential but refuses to use adequate contraception during the study.
- Patient has had previous bariatric or gastric surgery.
- Patient has a history of acute pancreatitis.
- Patient has a history of small bowel obstructions.
- Patients with a history of abdominal and/or pelvic surgery EXCLUDING only ONE of the following surgeries that was performed at least 12 months prior to the Elipse™ Treatment: 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 they would be excluded. If a patient had one cesarean section they may be included.)
- Patient has history of/or signs and/or symptoms of esophageal, gastric, or duodenal disease including but not limited to hiatal hernias \>2 centimeter (cm), inflammatory diseases, cancer, and varices.
- Patient has a specific diagnosed genetic or hormonal cause for obesity such as hypothyroidism or PraderWilli syndrome.
- Patient has poorly controlled diabetes.
- Patient has renal and/or hepatic insufficiency.
- Patient has systemic infection or abscess at the site to be treated.
- Patient is undergoing chronic steroid therapy.
- Patient is undergoing immunosuppressive therapy.
- Patient is presently taking heparin, coumadin, warfarin, or other anticoagulants or other medications which impede coagulation or platelet aggregation.
- Patient is unable or unwilling to discontinue use of aspirin and/or non-steroidal anti-inflammatory agents (NSAIDs) at least 14 days prior to treatment and continuing for 14 days post-treatment.
- Patient has a history of pulmonary embolism or blood coagulation disorders.
- Patient is unable to discontinue either prescription or over the counter weight loss medications at least 30 days prior to treatment and continuing for the remainder of the trial
- Patient has cardiac pacemaker or other electric implantable device.
- Patient has a history of using any tobacco products including but not limited to cigars, cigarettes, and pipes within 12 months prior to enrollment.
- Patient has poorly controlled psychiatric disease such as depression.
- Patient has eating disorders including night eating syndrome (NES), Bulimia, or binge eating disorder, or who continuously graze on food for the majority of the day.
- Patient has uncontrolled life stressors at baseline such as divorce, or illness/death of personal acquaintances.
- Patient currently uses or has a history of illicit drug use or excessive alcohol use.
- Patient has participated in a clinical study with an investigational new drug, biological, or therapeutic device within ≤ 28 days prior to enrollment in this trial, and does not agree to abstain from participation in other clinical trials of any kind during this trial.
- Patient is not of sufficient medical health as determined by the PI to participate in the trial.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT02802007
Start Date
August 1 2014
Last Update
June 16 2016
Active Locations (2)
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1
Ostrava University Hospital
Ostrava, Czechia
2
Iatriko Palaiou Faliro
Athens, Greece