A Study to Test the Safety and Effectiveness of the Spatz3 Adjustable Balloon System to Help Obese People Lose Weight

Overview

About this study

The purpose of this study is to evaluate the safety and effectiveness of the Spatz3 in subjects with a BMI ≥ 30 and < 40 who have failed to achieve and maintain weight-loss with a weight control program.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Age 22 - 65
  • BMI ≥ 30 and <40
  • Willingness to comply with the substantial lifelong dietary restrictions required by the procedure
  • History of obesity (BMI ≥ 30) for at least 2 years
  • History of failure with non-surgical weight loss methods
  • Willingness to follow protocol requirements, including
    • Signed informed consent
    • Routine follow-up schedule
    • Completing laboratory tests
    • Completing diet counseling
  • Residing within a reasonable distance from the investigator’s office and able to travel to the investigator to complete all routine follow- up visits
  • Ability to give informed consent
  • Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods
    • Acceptable birth control methods are limited to hormonal contraceptives (oral, flexible vaginal ring, skin patch, injection), diaphragms, IUDs, condoms with or without spermicide, and voluntary abstinence
    • The method of birth control must be documented and verified at follow-up
    • If a treatment subject becomes pregnant during the implantation period, the balloon will be extracted during the second trimester - the timing of which will be determined via consultation with the subject’s obstetrician   

Exclusion Criteria

  • Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions
  • Prior open or laparoscopic bariatric surgery
  • Prior surgery of any kind on the esophagus, stomach or any type of hiatal hernia surgery
  • Any inflammatory disease of the gastrointestinal tract including esophagitis, Barrett’s esophagus, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn’s disease
  • Potential upper gastrointestinal bleeding condition such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses
  • A gastric mass
  • A hiatal hernia > 2cm 
  • Severe or intractable gastro-esophageal reflux symptoms
  • Acid reflux symptoms to any degree that require more than one medication for symptom control
  • A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the balloon alongside the endoscope
  • Achalasia or any other severe esophageal motility disorder that may pose a safety risk during the removal of the device
  • Severe coagulopathy
  • Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months
  • Any serious health condition unrelated to weight that would increase the risk of endoscopy
  • Chronic abdominal pain
  • Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation
  • Hepatic insufficiency or cirrhosis
  • Serious or uncontrolled psychiatric illness or disorder that could compromise patient understanding of or compliance with follow up visits and removal of the device after 8 months
  • Alcoholism or drug addiction
  • Unwillingness to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up
  • Receiving daily prescribed treatment with aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants
  • Unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant
  • Known to have, or suspected to have, an allergic reaction to materials contained in the system
  • Has ever developed a serotonin syndrome and is currently taking any drug known to affect the levels of serotonin in the body [e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs)] should not undergo placement of the device
  • Is pregnant or breast-feeding
  • Has severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, Myocardial infarction within the past 6 months, poorly-controlled hypertension, required use of NSAIDs
  • Has tested positive for H. Pylori
  • Is taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications
  • Is taking corticosteroids, immunosuppressants, or narcotics
  • Is taking diet pills
  • Use of an intragastric device prior to this study, due to the potential increase in risk associated with implantation of a balloon in a previously instrumented and possibly scarred stomach
  • Participation in any clinical study which could affect weight loss within the past 6 months, due to the potential to confound findings
  • 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
  • Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous, scleroderma) or is immunocompromised
  • Life expectancy less than 1 year or has severe renal, hepatic, pulmonary or other medical condition in the opinion of the investigator, because of an increased risk profile
  • Specific diagnosed genetic or hormonal cause for obesity such as hypothyroidism or Prader Willi syndrome
  • Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating
  • Known history of endocrine disorders affecting weight

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Barham Abu Dayyeh, M.D., M.P.H.

Closed for enrollment

More information

Publications

Publications are currently not available
.

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