Any Gastric Condition Which Requires Capsule EndoscopyNOISENCT02775708
Development of Applications of the ® PillCam Endoscopy System and Evaluation of Their Performance
A study testing Pillcam endoscopy system in people with Any Gastric Condition Which Requires Capsule Endoscopy, run by Medtronic - MITG at 2 sites in 2 countries.
Trial summary
The purpose of this study is to support development of PillCam Endoscopy System applications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Any Gastric Condition Which Requires Capsule Endoscopy
- What is being tested?
- Pillcam endoscopy system
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2016to 24 Oct 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject's from 18 years of age.
- Subject is indicated for Capsule Endoscopy procedure.
- Subject agrees to sign the Informed Consent Form.
Who cannot join
- Female subject is pregnant.
- Subject is known or is suspected to suffer from intestinal obstruction (symptoms such as severe abdominal pain with accompanying nausea or vomiting).
- Subject has a pacemaker or other implanted electro-medical device.
- Subject has any condition, which precludes compliance with study and/or device instructions, such as swallowing problems.
- Subject suffers from life threatening conditions.
- Subject is currently participating in another clinical study that may directly or indirectly affect the results of this study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The purpose of this study is to support development of PillCam Endoscopy System applications.
- Being tested
- Pillcam endoscopy system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pillcam endoscopy systemDevice
| Study group | Role | What they receive |
|---|---|---|
| capsule endoscopy | Experimental | open label arm ; up to 100 subjects indicated for capsule endoscopy (CE) procedure will undergo the CE procedure with the Pillcam endoscopy system Receives: Device: Pillcam endoscopy system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of gaps in the RAPID video will be assessed
Measured: capsule endoscopy procedure day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startMar 2016
- Primary completion19 Sep 2017
- Study completion24 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Any Gastric Condition Which Requires Capsule EndoscopyStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775708
- Sponsor's protocol ID
- COVGIRD0477
- Acronym
- NOISE
- Status last verified
- Sep 2017
- First submitted
- 20 Apr 2016
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Applications of the ® PillCam Endoscopy System and Evaluation of Their Performance
- ClinicalTrials.gov ID
- NCT02775708
- Acronym / sponsor ID
- NOISE / COVGIRD0477
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Mar 2016 (actual)
- Primary completion
- 19 Sep 2017 (actual)
- Study completion
- 24 Oct 2017 (actual)
- First posted
- 18 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to support development of PillCam Endoscopy System applications.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| capsule endoscopy | Experimental | Device: Pillcam endoscopy systemopen label arm ; up to 100 subjects indicated for capsule endoscopy (CE) procedure will undergo the CE procedure with the Pillcam endoscopy system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject's from 18 years of age.
- Subject is indicated for Capsule Endoscopy procedure.
- Subject agrees to sign the Informed Consent Form.
Key exclusion criteria (6 listed)
- Female subject is pregnant.
- Subject is known or is suspected to suffer from intestinal obstruction (symptoms such as severe abdominal pain with accompanying nausea or vomiting).
- Subject has a pacemaker or other implanted electro-medical device.
- Subject has any condition, which precludes compliance with study and/or device instructions, such as swallowing problems.
- Subject suffers from life threatening conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pillcam endoscopy system | Device | capsule endoscopy |
Primary outcome
Number of gaps in the RAPID video will be assessed
Time frame: capsule endoscopy procedure day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pillcam endoscopy system in people with Any Gastric Condition Which Requires Capsule Endoscopy, run by Medtronic - MITG at 2 sites in 2 countries.
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 6 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: finished, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Spain. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of gaps in the RAPID video will be assessed (time frame: capsule endoscopy procedure day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2017.