Evaluation of a Low-Cost High Resolution Microendoscope f... | NCT01384240

Studies
Evaluation of a Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia

NCT01384240

Sponsor

Anandasabapathy, Sharmila, M.D.

Status

Terminated

Last Update Posted

Jan 12, 2016Estimated

Enrollment

183Actual

Phase

Early Phase 1

Conditions

Colon Polyps
Colonic Dysplasia
Anal Dysplasia

Interventions

Proflavine Hemisulfate

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study is closed as the PI transferred to another institution.

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Jul 2013Actual

Completion Date

May 2014Actual

First Submitted Date

Jun 27, 2011

First Submission Date that Met QC Criteria

Jun 27, 2011

First Posted Date

Jun 29, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 8, 2016

Last Update Posted Date

Jan 12, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

183Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Proflavine Hemisulfate	Experimental		Drug: Proflavine Hemisulfate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Proflavine Hemisulfate	Drug	3-ml of 0.01% proflavine(derived from dissolving 10 mg proflavine hemisulfate USP in 100 ml sterile water)	Proflavine Hemisulfate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to determine whether tissue in nepoplastic or non-neoplastic		1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

surveillance of polyps or disease of the colon
screening colonoscopy
anoscopy for suspected or known anal dysplasia or neoplasia

Exclusion Criteria:

unfit for standard colonoscopy or anoscopy
unable to provide informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sharmila Anandasabapathy, MD	Icahn School of Medicine at Mount Sinai	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mount Sinai Medical Center		New York	New York	10029	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23780842	Derived	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.

ID	Term
D007417	Intestinal Polyps
D011127	Polyps
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000609	Aminoacridines
D000166	Acridines
D006575	Heterocyclic Compounds, 3-Ring
D000072471	Heterocyclic Compounds, Fused-Ring