Colon PolypsEarly Phase 1NCT01384240
Evaluation of a Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia
A Early Phase 1 study testing Proflavine Hemisulfate in people with Colon Polyps and Colonic Dysplasia, run by Anandasabapathy, Sharmila, M.D. at 1 site in United States.
Trial summary
The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of the colon can assist clinicians in detecting dysplastic (precancerous) and neoplastic areas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Polyps, Colonic Dysplasia, Anal Dysplasia
- What is being tested?
- Proflavine Hemisulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to May 2014
- Phase
- Early Phase 1
- 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
- surveillance of polyps or disease of the colon
- screening colonoscopy
- anoscopy for suspected or known anal dysplasia or neoplasia
Who cannot join
- unfit for standard colonoscopy or anoscopy
- unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Medical Center
New York, New York, 10029
About this study
Official title: Evaluation of Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia
The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of the colon can assist clinicians in detecting dysplastic (precancerous) and neoplastic areas. This is a pilot study of a novel technology, a miniaturized microscope device which can be used during standard endoscopy to image the gastrointestinal epithelium. Theoretically, by visualizing superficial mucosal changes at a high-resolution and magnification, the investigators will be able to obtain optical images that can be used to guide endoscopic biopsy and polypectomy. This may foster the selective targeting of dysplasia/neoplasia, thereby improving diagnostic accuracy.
- Conditions
- Colon Polyps, Colonic Dysplasia, Anal Dysplasia
- Being tested
- Proflavine Hemisulfate
- Keywords
- colon polyps, colonic dysplasia, anal dysplasia, microendoscopy
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proflavine HemisulfateDrug
Also called Proflavine
3-ml of 0.01% proflavine(derived from dissolving 10 mg proflavine hemisulfate USP in 100 ml sterile water)
| Study group | Role | What they receive |
|---|---|---|
| Proflavine Hemisulfate | Experimental | Not described Receives: Drug: Proflavine Hemisulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine whether tissue in nepoplastic or non-neoplastic
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study startApr 2010
- Primary completionJul 2013
- Study completionMay 2014
Why it stopped: Study is closed as the PI transferred to another institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon PolypsStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anandasabapathy, Sharmila, M.D.
- Responsible party
- Sponsor
- Investigators
- Sharmila Anandasabapathy, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384240
- Sponsor's protocol ID
- GCO# 09-1040
- Status last verified
- Jan 2016
- First submitted
- 27 Jun 2011
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chang SS, Shukla R, Polydorides AD, Vila PM, Lee M, Han H, Kedia P, Lewis J, Gonzalez S, Kim MK, Harpaz N, Godbold J, Richards-Kortum R, Anandasabapathy S. High resolution microendoscopy for classification of colorectal polyps. Endoscopy. 2013 Jul;45(7):553-9. doi: 10.1055/s-0032-1326502. Epub 2013 Jun 18.
PubMed 23780842
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia
- ClinicalTrials.gov ID
- NCT01384240
- Acronym / sponsor ID
- GCO# 09-1040
- Conditions
- Colon Polyps, Colonic Dysplasia, Anal Dysplasia
- Keywords
- colon polyps, colonic dysplasia, anal dysplasia, microendoscopy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study is closed as the PI transferred to another institution.
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Anandasabapathy, Sharmila, M.D.
- Study start
- Apr 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 29 Jun 2011 (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 overall objective of this study is to obtain data to evaluate whether high-resolution imaging of the colon can assist clinicians in detecting dysplastic (precancerous) and neoplastic areas. This is a pilot study of a novel technology, a miniaturized microscope device which can be used during standard endoscopy to image the gastrointestinal epithelium. Theoretically, by visualizing superficial mucosal changes at a high-resolution and magnification, the investigators will be able to obtain optical images that can be used to guide endoscopic biopsy and polypectomy. This may foster the selective targeting of dysplasia/neoplasia, thereby improving diagnostic accuracy.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proflavine Hemisulfate | Experimental | Drug: Proflavine Hemisulfate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- surveillance of polyps or disease of the colon
- screening colonoscopy
- anoscopy for suspected or known anal dysplasia or neoplasia
Key exclusion criteria (2 listed)
- unfit for standard colonoscopy or anoscopy
- unable to provide informed consent
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 |
|---|---|---|
| Proflavine HemisulfateAlso: Proflavine3-ml of 0.01% proflavine(derived from dissolving 10 mg proflavine hemisulfate USP in 100 ml sterile water) | Drug | Proflavine Hemisulfate |
Primary outcome
to determine whether tissue in nepoplastic or non-neoplastic
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Study is closed as the PI transferred to another institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
- Derived from this study: PubMed 23780842Chang SS, Shukla R, Polydorides AD, Vila PM, Lee M, Han H, Kedia P, Lewis J, Gonzalez S, Kim MK, Harpaz N, Godbold J, Richards-Kortum R, Anandasabapathy S. High resolution microendoscopy for classification of colorectal polyps. Endoscopy. 2013 Jul;45(7):553-9. doi: 10.1055/s-0032-1326502. Epub 2013 Jun 18.
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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.
Sharmila Anandasabapathy, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Proflavine Hemisulfate in people with Colon Polyps and Colonic Dysplasia, run by Anandasabapathy, Sharmila, M.D. 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 2 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 12 Jan 2016. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study is closed as the PI transferred to another institution.). 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?
to determine whether tissue in nepoplastic or non-neoplastic (time frame: 1 day). 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 NCT01384240, which also lists 1 linked publication.
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 12 Jan 2016.