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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03301909
Recruitment Status : Suspended (COVID-19)
First Posted : October 4, 2017
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Device: PillCam™ Endoscopy System Drug: Bowel prep combination Not Applicable

Detailed 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: PillCam™ Endoscopy System

PillCam™ Endoscopy System consists of the following subunits (the dates bellow represent the initial marketing approvals):

  • PillCam™ Capsule products' family (latest model):

    1. PillCam COLON 2
    2. PillCam UGI (upper gastrointestinal)
    3. PillCam SB3 (small bowel 3)
    4. PillCam Crohn's capsule
  • Patency capsule:

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.

  • PillCam Recorder
  • PillCam Sensor Arrays & Sensor Belt
  • PillCam™ Software v. 9
  • Workstation unit
  • Patency scanner
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject either male or female is 18-85 years of age.
  2. The subject is in good general health to enable participation in the study.
  3. The subject received an explanation and understands the nature of the study and agrees to provide written informed consent.

Exclusion Criteria:

  1. Subject has dysphagia or any swallowing disorder.
  2. Subject is known or is suspected to suffer from intestinal obstruction or stricture (symptoms such as severe abdominal pain with accompanying nausea or vomiting).
  3. Patient with known gastrointestinal motility disorders.
  4. Subjects with known or suspected delayed gastric emptying.
  5. Subject has known or suspected Crohn's disease, other inflammatory bowel disease, perforations or structural disorders of the gut wall.
  6. Subject has diabetes.
  7. 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.
  8. Subject has any allergy or other contraindication to any materials including preparation used prior, during or after capsule endoscopy in the study.
  9. Patient is expected to undergo MRI examination within 7 days after ingestion of the capsule.
  10. Subject has severe congestive heart failure or known renal or hepatic insufficiency.
  11. Subject has a cardiac pacemakers or other implanted electromedical devices.
  12. Subject has any condition, which according to the investigators judgment, precludes compliance with study and/or device instructions.
  13. 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.
  14. Subject is currently participating in another clinical study that may directly or indirectly affect the results of this study.
  15. Subject is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity).

Information from the National Library of Medicine

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


Locations
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Israel
Medtronic - Glilee Medical Center
Yoqne'am 'Illit, Israel
Sponsors and Collaborators
Medtronic - MITG
Investigators
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Principal Investigator: Wisam Sbeit, M.D Galil MC, Nahariya
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Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT03301909    
Other Study ID Numbers: MDT16024
First Posted: October 4, 2017    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No