Measuring the Spectrum of Tissues During Endoscopy | NCT00996619

Studies
Measuring the Spectrum of Tissues During Endoscopy

NCT00996619

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Oct 16, 2009Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Colon Carcinoma
Colonic Polyps
Intestinal Polyps

Interventions

An optical fiber, inside the work channel of an endoscope, is added to the endoscopic examination

Countries

Israel

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

Oct 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

May 2010Estimated

Completion Date

May 2010Estimated

First Submitted Date

Sep 29, 2009

First Submission Date that Met QC Criteria

Oct 15, 2009

First Posted Date

Oct 16, 2009Estimated

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

Oct 15, 2009

Last Update Posted Date

Oct 16, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Lesions, polyps and other abnormalities in the gastrointestinal (GI) tract have a different composition compared to the normal mucose. The investigators plan to gather spectroscopic information from these features. Characterizing their unique spectrums, may help to enhance the detection and identification of these objects during endoscopy.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
People undergoing GI tract endoscopy			Procedure: An optical fiber, inside the work channel of an endoscope, is added to the endoscopic examination

Interventions

Name	Type	Description	Arm Group Labels	Other Names
An optical fiber, inside the work channel of an endoscope, is added to the endoscopic examination	Procedure	An optical fiber, inside the work channel of an endoscope, connected to a spectroscope, enables measuring the spectrum of objects "seen" by the endoscope

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult, independent patients who come to Sheba Hospital's gastro-intestinal clinic for endoscopy and are willing to sign an informed consent

Exclusion Criteria:

None

Accepts Healthy Volunteers

Yes

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

Independent Adults

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Arie Orenshtein, Prof.	Contact	+97235303114		Arie.Orenstein@sheba.health.gov.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Medical Center		Tel Litwinsky		52621	Israel

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms
D003111	Colonic Polyps
D007417	Intestinal Polyps

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided