METHOD (Minimally Invasive, Endoscopically-delivered, Tolerable by Human Individuals, Non-morbid Obesity Device) Study
Condition: Obesity, Non-morbid
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be an open label, single-center, feasibility study comprised of two sequential
      cohorts( cohort 1: 2 participants; cohort 2: 8 participants).

      This study will be conducted in generally healthy participants aged 25 to 55 years with
      non-morbid obesity and a pre-screening body mass index between 35 and 40.

      Participants will undergo screening to determine their health status and their eligibility to
      participate in the study. Eligible patients will undergo an endoscopic device delivery
      procedure during which the device will be anchored in the inner stomach wall at the distal
      anterior antrum. Physical examination and/or endoscopic safety evaluations will be conducted
      on day 14 and 28. The device and its anchor will be completely removed endoscopically after 8
      weeks. The participants will be followed-up for safety evaluation for an additional period of
      2 weeks.
    

Detailed description: 
      Effective and safe methods are required to achieve substantial and long-lasting weight-loss
      with minimal and preferably no impact on the non-morbid obese individuals' pre-procedure
      lifestyle. The current available treatments for obesity in general and non-morbid obesity in
      particular, are, for the most part, ineffective in the long run and are associated with
      material adverse events and potentially lethal complications.

      Sensate™, is an endoscopically-delivered, inner-stomach-wall-anchored, low-profile device
      (practically the exact size and shape of the famous Given Imaging PillCam™ swallowable
      device), which is advantageous in comparison to both open and minimally invasive surgical
      methods for treating obesity. The reason for that is because of the simple endoscopic
      delivery, inner-antrum-wall-anchoring and removal procedures are safe, minimally-invasive,
      requiring minimal participant sedation (not deep anesthesia), not requiring unique
      gastroenterologist skills, and can be done in an outpatient clinic setting just like in the
      hospital setting. Moreover, Sensate™ is designed to modestly reduce food consumption
      concurrently with the generation of greater satiety, and thus maintain balanced and healthier
      weight loss over a long period of time without mandating complementary radical lifestyle
      changes and nutritional changes which have been proven to be very hard and impractical on the
      obese individual.

      This study will be the first study in humans, and it is focused on examining and validating
      the safety, tolerability and preliminary efficacy of Sensate™ in humans.

      The Sensate™ study is comprised of two sequential cohorts of generally healthy patients with
      non-morbid obesity, with two participants in the first cohort and eight subjects in the
      second cohort. The first cohort is starting with just 2 subjects, in order to validate the
      absolute safety of the device and its delivery before additional subjects are being
      recruited. The sample size is the minimal one required to collect safety, tolerability and
      preliminary efficacy data. Participants will undergo screening to determine their health
      status and their eligibility to participate in the study. Screening examinations include
      medical history, physical examination, vital signs, weight measurement and laboratory
      assessments. Eligible patients will undergo an endoscopic device delivery procedure during
      which the device will be anchored in the inner stomach wall at the distal anterior antrum.
      Patients will be requested to complete a detail daily diary based on visual analogue scale
      (VAS) to record their eating sensations during and after each meal throughout the study.
      Physical examination, recording of adverse events and weight measurements will be conducted
      on day 14 and 28. In addition, phone calls are made every week during the study period to ask
      the patient about any health alterations. Endoscopic safety evaluation to validate that the
      device is anchored properly with no safety issues will be performed on Days 14 and 28 in the
      first two subjects and at day 28 for the remaining eight subjects. The device and its anchor
      will be completely removed endoscopically after 8 weeks. The participants will be followed-up
      for safety evaluation for an additional period of 2 weeks. Safety evaluations include
      physical examination, vital signs, adverse events and laboratory assessments.
    

Intervention name(s): Sensate™ anchored gastric device
Intervention type(s): Device
Intervention description(s): Delivery/anchoring of the Sensate™ device in the stomach. Withdrawal of the Sensate™ device and its anchoring components after 8 weeks.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity