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HealthyNCT03301909

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

A study testing PillCam™ Endoscopy System and Bowel prep combination in people with Healthy, run by Medtronic - MITG at 1 site in Israel.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 45 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
PillCam™ Endoscopy System and Bowel prep combination
Could I receive a placebo?
No, everyone receives an active treatment
How many people
694 participants
Where
1 siteIsrael
Study dates
10 Apr 2018to 31 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Medtronic - Glilee Medical Center

    Yokneam Illit

Other trials in Israel

About this study

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.

Read the 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.

Conditions
Healthy
Being tested
PillCam™ Endoscopy System, Bowel prep combination

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PillCam™ Endoscopy SystemDevice

    Subject may be assigned to any procedure involving modification of any of the PillCam™ Endoscopy System component as listed in the arm description.

  • Bowel prep combinationDrug

    Subject may be assigned to any bowel preparation combination.

Study groups in NCT03301909
Study groupRoleWhat they receive
PillCam™ Endoscopy SystemExperimentalPillCam™ 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
Receives: Device: PillCam™ Endoscopy System; Drug: Bowel prep combination

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All device related Adverse events will be collected and reported in order to assess the device safety.

    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.

    Measured: Up to 10 years

Secondary outcomes (1)

  1. Assessment of raw data generation in the data recorder by confirming presence of the procedure raw data output files (technical outcome)

    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.

    Measured: Up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2017
  2. Study start10 Apr 2018
  3. Primary completion27 Mar 2023
  4. Study completion31 Mar 2023

Why it stopped: Study purposes and objectives have shifted

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
694 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03301909
Sponsor's protocol ID
MDT16024
Status last verified
Jan 2024
First submitted
29 Sep 2017
Last updated
10 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing PillCam™ Endoscopy System and Bowel prep combination in people with Healthy, run by Medtronic - MITG at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Study purposes and objectives have shifted). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All device related Adverse events will be collected and reported in order to assess the device safety. (time frame: Up to 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03301909.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.

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