Development of Applications of PillCam™ Endoscopy and Patency Systems and Clinical Evaluation of Their Performance in Healthy Volunteers ("HEIGHT" Study)
NCT03301909 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 694
Last updated 2024-01-10
Summary
This is a feasibility, prospective, single center, open label, uncontrolled clinical study, to evaluate the safety and preliminary efficacy of the different R\&D changes made and implemented in the existing PillCam Capsule products family, PillCam Endoscopy System subunits, the Patency system and bowel preparation procedure.
Conditions
- Healthy
Interventions
- DEVICE
-
PillCam™ Endoscopy System
Subject may be assigned to any procedure involving modification of any of the PillCam™ Endoscopy System component as listed in the arm description.
- DRUG
-
Bowel prep combination
Subject may be assigned to any bowel preparation combination.
Sponsors & Collaborators
-
Medtronic - MITG
lead INDUSTRY
Principal Investigators
-
Wisam Sbeit, M.D · Galil MC, Nahariya
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 45 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-04-10
- Primary Completion
- 2023-03-27
- Completion
- 2023-03-31
Countries
- Israel
Study Locations
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