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METHOD (Minimally Invasive, Endoscopically-delivered, Tolerable by Human Individuals, Non-morbid Obesity Device) Study

NCT00753350 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2013-03-04

No results posted yet for this study

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.

Conditions

  • Obesity, Non-morbid

Interventions

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.

Sponsors & Collaborators

  • Johannes Gutenberg University Mainz

    collaborator OTHER

  • Sensate LLC

    lead INDUSTRY

Principal Investigators

  • Ralf Kiesslich, Univ.-Prof. Dr. med. · Johannes Gutenberg University Mainz, I. Med. Klinik und Poliklinik

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00753350 on ClinicalTrials.gov