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

January 8, 2024 updated by: Medtronic - MITG
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
694

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Israel
      • Yoqne'am 'Illit, Israel
        • Medtronic - Glilee Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Subject either male or female is 45-85 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. Subject 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. Subject 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PillCam™ Endoscopy System

PillCam™ Endoscopy System consists of the following subunits:

  • PillCam™ Capsule products' family:

    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 are part of the Pillcam™ systems:

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
All device related Adverse events will be collected and reported in order to assess the device safety.
Time Frame: Up to 10 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.
Up to 10 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of raw data generation in the data recorder by confirming presence of the procedure raw data output files (technical outcome)
Time Frame: Up to 10 years
A PillCam procedure will be assessed for raw data generation in the data recorder (similar to standard of care procedure), by confirming presence of the procedure output files (technical outcome). A nominal scale of Yes/No will be used to determine whether the raw data has been generated by the data recorder or not.
Up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic - MITG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wisam Sbeit, M.D, Galil MC, Nahariya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 27, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MDT16024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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