Colonic PolypsNCT01979458
Photometric Stereo Endoscopy (PSE) as a Tool for Imaging the Rectum and Colon
A study testing PSE in people with Colonic Polyps, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The goal of this research is to assess photometric stereo endoscopy (PSE) as an endoscopic imaging technique. Specifically, topographical surface contrast reconstructed from the PSE data will be compared to conventional imaging contrast to assess if PSE provides enhanced contrast of abnormal tissue. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colonic Polyps
- What is being tested?
- PSE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jul 2014
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing a routine colonoscopy screening
- Patients must be over the age of 18
- Patients must be able to give informed consent
Who cannot join
- Patients with bleeding/hemostasis disorders
- Patients that are pregnant
- Patients taking any anti-coagulants that would preclude them from undergoing a standard of care colonoscopy, such as Coumadin and Plavix, at the time of the study
- Patients with known colitis or active bleeding will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Pilot Study to Evaluate Photometric Stereo Endoscopy (PSE) as a Tool for Imaging the Rectum and Colon
The goal of this research is to assess photometric stereo endoscopy (PSE) as an endoscopic imaging technique. Specifically, topographical surface contrast reconstructed from the PSE data will be compared to conventional imaging contrast to assess if PSE provides enhanced contrast of abnormal tissue.
- Conditions
- Colonic Polyps
- Being tested
- PSE
- Keywords
- Colonoscopy
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSEDevice
Also called photometric stereo endoscopy
| Study group | Role | What they receive |
|---|---|---|
| PSE | Experimental | Patients whose distal colon is imaged using the PSE device. This is a pilot trial of 30 patients. Receives: Device: PSE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image Contrast
Comparison of image contrast obtained using standard colonoscopy and PSE.
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norman Nishioka, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979458
- Sponsor's protocol ID
- 2013P001115
- Status last verified
- Sep 2014
- First submitted
- 4 Nov 2013
- Last updated
- 24 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate Photometric Stereo Endoscopy (PSE) as a Tool for Imaging the Rectum and Colon
- ClinicalTrials.gov ID
- NCT01979458
- Acronym / sponsor ID
- 2013P001115
- Conditions
- Colonic Polyps
- Keywords
- Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 8 Nov 2013 (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 goal of this research is to assess photometric stereo endoscopy (PSE) as an endoscopic imaging technique. Specifically, topographical surface contrast reconstructed from the PSE data will be compared to conventional imaging contrast to assess if PSE provides enhanced contrast of abnormal tissue.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PSE | Experimental | Device: PSEPatients whose distal colon is imaged using the PSE device. This is a pilot trial of 30 patients. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing a routine colonoscopy screening
- Patients must be over the age of 18
- Patients must be able to give informed consent
Key exclusion criteria (4 listed)
- Patients with bleeding/hemostasis disorders
- Patients that are pregnant
- Patients taking any anti-coagulants that would preclude them from undergoing a standard of care colonoscopy, such as Coumadin and Plavix, at the time of the study
- Patients with known colitis or active bleeding will be excluded
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 |
|---|---|---|
| PSEAlso: photometric stereo endoscopy | Device | PSE |
Primary outcome
Image Contrast
Time frame: Immediate
Comparison of image contrast obtained using standard colonoscopy and PSE.
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 24 Mar 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSE in people with Colonic Polyps, run by Massachusetts General Hospital at 1 site in United States.
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 4 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 24 Mar 2017. 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 United States. 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?
Image Contrast (time frame: Immediate). 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 24 Mar 2017.