| Eligibility |
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)
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