Development of Applications of PillCam™ Endoscopy and Patency Systems and Clinical Evaluation of Their Performance in Healthy Volunteers ("HEIGHT" Study)
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|ClinicalTrials.gov Identifier: NCT03301909|
Recruitment Status : Suspended (COVID-19)
First Posted : October 4, 2017
Last Update Posted : April 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Device: PillCam™ Endoscopy System Drug: Bowel prep combination||Not Applicable|
The study consists of a screening - enrollment phase, a possible preparation phase followed by the PillCam Endoscopy or Patency procedure visit and a post procedure telephone, follow up visit.
Subjects may be assigned to any of the testing's done within this study as long as they fulfill all the inclusion and exclusion criteria's and depends on their availability and their willingness to participate in a specific testing. The decision to assign a subject to a specific testing is done based on subject's availability.
Each subject may ingest up to 15 capsules (PillCam, Patency) during his/her participation in the study, each ingestion will be separated in between by at least two weeks interval. A following capsule may be ingested only upon verification of previous capsule excretion.
In general, under the study protocol, per a single procedure, each subject will undergo a possible preparation phase followed by the PillCam endoscopy or Patency procedure and telephone follow up visit. Overall the expected duration for subject's participation in the study is expected to be up to 5 years, until subject will complete up to 15 PillCam Capsule ingestions.
Subject may withdraw consent at any time and will be considered as completed once completed at least one capsule ingestion (PillCam or Patency) or completed one of the possible procedures which are not involving capsule ingestion during the study period.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Development of Applications of PillCam™ Endoscopy and Patency Systems and Clinical Evaluation of Their Performance in Healthy Volunteers ("HEIGHT" Study)|
|Actual Study Start Date :||April 10, 2018|
|Estimated Primary Completion Date :||November 2022|
|Estimated Study Completion Date :||November 2022|
Experimental: PillCam™ Endoscopy System
PillCam™ Endoscopy System consists of the following subunits (the dates bellow represent the initial marketing approvals):
PillCam Patency capsule
All the bellow system subunits as applicable, are part of the regulatory approval status mentioned alongside each of the Pillcam and Patency systems.
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.
- All device related Adverse events will be collected and reported in order to assess the device safety. [ Time Frame: Up to 5 years ]All device related Adverse events will be reported by number, type, seriousness, severity and duration. All device related adverse events will be captured, regardless of severity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03301909
|Medtronic - Glilee Medical Center|
|Yoqne'am 'Illit, Israel|
|Principal Investigator:||Wisam Sbeit, M.D||Galil MC, Nahariya|