METHOD (Minimally Invasive, Endoscopically-delivered, Tolerable by Human Individuals, Non-morbid Obesity Device) Study (SENSATE)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label, Single-center, Feasibility Study Designed to Evaluate the Safety and Tolerability of Sensate™ Anchored Gastric Device in Subjects With Non-morbid Obesity|
- Adverse Events (subjective participant reporting or documentation). [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Vital signs. Laboratory tests. Pathological findings in physical Examination and in endoscopic examination of stomach. Concomitant medication use. Body weight measurements. Improved VAS-based score. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2008|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Sensate™ anti-Obesity device
Device: Sensate™ anchored gastric device
Delivery/anchoring of the Sensate™ device in the stomach. Withdrawal of the Sensate™ device and its anchoring components after 8 weeks.
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.
|Johannes Gutenberg University, I. Med. Klinik|
|Mainz, Rheinland-Pfalz, Germany, 55131|
|Principal Investigator:||Ralf Kiesslich, Univ.-Prof. Dr. med.||Johannes Gutenberg University Mainz, I. Med. Klinik und Poliklinik|