Development of Applications of PillCam™ Endoscopy and Patency Systems and Clinical Evaluation of Their Performance in Healthy Volunteers ("HEIGHT" Study)

  • STATUS
    Recruiting
  • End date
    Jan 29, 2028
  • participants needed
    2000
  • sponsor
    Medtronic - MITG
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Updated on 29 May 2022
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Accepts healthy volunteers

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.

Description

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 sub-assays done within this study as long as they fulfill all the inclusion and exclusion criteria and depends on their availability and their willingness to participate in a specific sub-assay.

Each subject may participate in up to 15 sub-assays 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. Subjects can participate in a specific sub-assay only once.

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 10 years, until subject will complete participation in up to 15 sub-assays.

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.

Details
Condition Healthy
Treatment PillCam™ Endoscopy System, Bowel prep combination
Clinical Study IdentifierNCT03301909
SponsorMedtronic - MITG
Last Modified on29 May 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Subject either male or female is 45-85 years of age
The subject is in good general health to enable participation in the study
The subject received an explanation and understands the nature of the study and agrees to provide written informed consent

Exclusion Criteria

Subject has dysphagia or any swallowing disorder
Subject is known or is suspected to suffer from intestinal obstruction or stricture (symptoms such as severe abdominal pain with accompanying nausea or vomiting)
Subject with known gastrointestinal motility disorders
Subjects with known or suspected delayed gastric emptying
Subject has known or suspected Crohn's disease, other inflammatory bowel disease, perforations or structural disorders of the gut wall
Subject has diabetes
Subject has undergone certain prior abdominal surgery of the gastrointestinal tract, (other than uncomplicated appendectomy or uncomplicated cholecystectomy) which may interfere with the study, such as small bowel or colonic resection. This will be evaluated by the investigator
Subject has any allergy or other contraindication to any materials including preparation used prior, during or after capsule endoscopy in the study
Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule
Subject has severe congestive heart failure or known renal or hepatic insufficiency
Subject has a cardiac pacemakers or other implanted electromedical devices
Subject has any condition, which according to the investigators judgment, precludes compliance with study and/or device instructions
Females who are pregnant or nursing at the time of screening and/or during the study period, or are of child bearing potential without medically acceptable methods of contraception
Subject is currently participating in another clinical study that may directly or indirectly affect the results of this study
Subject is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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