The Endure Study

The objective of the ENDURE study is to evaluate the safety and effectiveness, in the short term (30 days) and long term (12 months), of Onciomed’s Gastric Vest System™ (GVS) under well-controlled clinical conditions. The GVS is a revolutionary, minimally invasive, long-term implant that wraps around the stomach. The GVS enables surgeons to perform long-term gastric volume reduction surgery without removing portions of the stomach.

The Gastric Vest System™ is indicated for use in weight reduction for severely obese patients with a Body Mass Index (BMI) of at least 35 or a BMI of at least 30 with one or more co-morbidities.

If you are interested in learning more about the ENDURE study, please fill out our patient’s questionnaire and email us at info@onciomed.com

 

Caution: Gastric Vest System™ is an Investigational Device. It is not available for commercial use or for sale.

For Clinical Sites

Onciomed is continuously looking for progressive surgeons to participate as clinical sites and become key opinion leaders for our ENDURE study. If you are interested in participating as a clinical site, please fill out our site survey and email us at info@onciomed.com

Inclusion Criteria

All patients meeting the Inclusion/Exclusion criteria for this study are eligible to participate

  • Candidates qualified for weight loss surgery
  • Body mass index (BMI) ≥ 35 kg/m² or;
  • At least 5 years of obesity (BMI ≥ 30 kg/m² ) with at least one or more severe obesity related co-morbid conditions like diabetes and hypertension
  • Failure to lose weight or maintain it within 36 months preceding the screening date, after participation in either of the following:
  • A medically or commercially supervised weight loss program involving regular counseling regarding diet and exercise;
  • Use of diet drugs;
  • Agreement to sign a written informed consent;
  • Residing within a reasonable distance from the investigator’s treating office and able and willing to travel to the Investigator’s office to complete all routine follow-up visits;
  • Able to comply with all study requirements for the duration of the study, as outlined in the protocol;
  • If female, the patient must be postmenopausal for at least 1 year OR be surgically sterile, OR if of child bearing potential, not breast feeding, must be practicing birth control, be willing to avoid pregnancy for the period of study participation, have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline

Exclusion Criteria

All patients meeting the Inclusion/Exclusion criteria for this study are eligible to participate

  • Genetically-caused obesity, such as Prader-Willi syndrome;
  • History of and/or ongoing clinically significant conditions or disorders of the gastrointestinal (GI) tract, i.e., Irritable Bowel Disease, Gastroparesis;
  • Any abnormal stenosis or obstruction of the GI tract
  • History of/ signs and /or symptoms of duodenal or gastric ulcer;
  • Portal hypertension
  • Previous stomach or bowel surgery;
  • History of adhesive peritonitis;
  • Clinically significant and uncontrolled/unstable for general anesthesia or abdominal surgery;
  • Significant acute and/or chronic infections of any kind
  • Inability to walk 200 yards without assistance;
  • Chronic aspirin or other non steroidal anti-inflammatory agents, or other medications known to be gastric irritants, and not willingness to discontinue the use of these concomitant medications, anti-arrythmics, anti-anginal medications, anticoagulants or medications for congestive heart failure;
  • Bleeding disorder;
  • Anemia defined as either: Hemoglobin (Hb) value for females of < 11.0 g/dl, for males < 12.0 g/dl;
  • Abnormal red cell indices and iron deficiency;
  • Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months;
  • Any screening laboratory values outside of the normal range deemed clinically significant by the Investigator;
  • History or known allergies to the device materials;
  • Participation in other investigational study protocols. If a subject had recently completed participation in another drug or device study, the subject must have completed that study at least 30 days prior to being enrolled in this study;
  • Concomitant use of, or unwillingness to avoid any use of, weight loss medications, weight loss supplements, weight loss herbal preparations and/or participation in any non-study-related organized weight loss program (commercial or medical) at any time during the study, including online or smart phone applications to track or modify food intake, exercise regimens, or weight;
  • Undergoing chronic steroid or immunosuppressive therapy;
  • Unstable angina, MI within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity;
  • Smoking cessation within 3 months of study entry or plans to quit smoking during the study;
  • Major surgery, open biopsy or significant traumatic injury within 3 months prior to enrollment;
  • Serious or uncontrolled psychiatric illness or disorder that could compromise patient understanding of or compliance with study procedures;
  • Patients or family members with a known diagnosis or pre-existing symptoms of autoimmune connective tissue disease such as systemic lupus erythematosus or scleroderma;
  • Addiction to alcohol or drugs;
  • Any condition that, in the opinion of the Investigator, would compromise the well being of the patient or the study or prevent the patient from meeting or performing study requirements, including: the inability or unwillingness to sign the patient informed consent document; the inability to participate in all necessary study activities due to physical, mental, or writing and verbal limitations; and the inability or unwillingness to return for all required follow-up visits.