GERDEarly Phase 1NCT01384695
A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia -Project 1
A Early Phase 1 study testing Fluorescein and Proflavine hemisulfate in people with GERD and Barrett's Esophagus, 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 gastrointestinal mucosain vivo can assist clinicians in detecting dysplastic (precancerous) areas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GERD, Barrett's Esophagus
- What is being tested?
- Fluorescein and Proflavine hemisulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Feb 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
- patient 18 years or older
- colonoscopy for screening or surveillance of polyps or disease of colon
- anoscopy because of suspected or known anal dysplasia or neoplasia
Who cannot join
- patient unable to provide informed consent
- patient found unfit for standard colonoscopy or anoscopy with biopsies
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: A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia - Project 1
The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of the gastrointestinal mucosain vivo can assist clinicians in detecting dysplastic (precancerous) areas. This is an exploratory study of a confocal endoscope designed to evaluate the feasibility of using this FDA-approved device in the endoscopic surveillance of subjects at high-risk for neoplasia in the upper and lower GI tract. The confocal endoscope provides real-time in vivo microscopic images of the mucosa which resemble standard pathology.
- Conditions
- GERD, Barrett's Esophagus
- Being tested
- Fluorescein, Proflavine hemisulfate
- Keywords
- Barrett's esophagus, confocal microendoscopy
- Medical subject headings
- Gastroesophageal Reflux, Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoresceinDrug
fluorescent contrast agent, Fluorescein 5ml
Proflavine hemisulfateDrug
Also called Proflavine
3 ml of 0.01% proflavine (derived from dissolving 10mg proflavine hemisulfate USP in 100ml sterile water)
| Study group | Role | What they receive |
|---|---|---|
| Fluorescein | Experimental | Confocal imaging using contrast agent fluorescein Receives: Drug: Proflavine hemisulfate |
| Proflavine hemisulfate | Experimental | confocal imaging using contrast agent proflavine Receives: Drug: Fluorescein |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine whether tissue is neoplastic 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 startJun 2009
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: Low/no enrollment. No subjects were enrolled over the past year.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anandasabapathy, Sharmila, M.D.
- Responsible party
- Sponsor
- Investigators
- Sharmila Anandasabapathy, M.D., Principal investigator, Mt. Sinai School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384695
- Sponsor's protocol ID
- GCO# 09-0696 Project 1
- Status last verified
- Jan 2016
- First submitted
- 28 Jun 2011
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
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
- A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia - Project 1
- ClinicalTrials.gov ID
- NCT01384695
- Acronym / sponsor ID
- GCO# 09-0696 Project 1
- Conditions
- GERD, Barrett's Esophagus
- Keywords
- Barrett's esophagus, confocal microendoscopy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low/no enrollment. No subjects were enrolled over the past year.
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Anandasabapathy, Sharmila, M.D.
- Study start
- Jun 2009
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 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 gastrointestinal mucosain vivo can assist clinicians in detecting dysplastic (precancerous) areas. This is an exploratory study of a confocal endoscope designed to evaluate the feasibility of using this FDA-approved device in the endoscopic surveillance of subjects at high-risk for neoplasia in the upper and lower GI tract. The confocal endoscope provides real-time in vivo microscopic images of the mucosa which resemble standard pathology.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluorescein | Experimental | Drug: Proflavine hemisulfateConfocal imaging using contrast agent fluorescein |
| Proflavine hemisulfate | Experimental | Drug: Fluoresceinconfocal imaging using contrast agent proflavine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient 18 years or older
- colonoscopy for screening or surveillance of polyps or disease of colon
- anoscopy because of suspected or known anal dysplasia or neoplasia
Key exclusion criteria (2 listed)
- patient unable to provide informed consent
- patient found unfit for standard colonoscopy or anoscopy with biopsies
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 |
|---|---|---|
| Fluoresceinfluorescent contrast agent, Fluorescein 5ml | Drug | Proflavine hemisulfate |
| Proflavine hemisulfateAlso: Proflavine3 ml of 0.01% proflavine (derived from dissolving 10mg proflavine hemisulfate USP in 100ml sterile water) | Drug | Fluorescein |
Primary outcome
to determine whether tissue is neoplastic or non-neoplastic
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Low/no enrollment. No subjects were enrolled over the past year.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
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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, M.D. principal investigator
Mt. Sinai School of Medicine
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 Fluorescein and Proflavine hemisulfate in people with GERD and Barrett's Esophagus, 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: Low/no enrollment. No subjects were enrolled over the past year.). 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 is neoplastic 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?
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.