Hyperspectral Imaging Pre and Post Endovascular Intervention | NCT00768495

Studies
Hyperspectral Imaging Pre and Post Endovascular Intervention

NCT00768495

Sponsor

HyperMed

Status

Unknown status

Last Update Posted

Jun 4, 2009Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Chronic Limb Ischemia
Non-Healing Ulcers

Interventions

Not provided

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

Jun 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Dec 2009Estimated

Completion Date

Dec 2009Estimated

First Submitted Date

Oct 6, 2008

First Submission Date that Met QC Criteria

Oct 7, 2008

First Posted Date

Oct 8, 2008Estimated

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

Jun 2, 2009

Last Update Posted Date

Jun 4, 2009Estimated

Name	Class
Cardiac, Vascular & Thoracic Surgery Associates, P.C. (CVTSA)	UNKNOWN

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

This trial will collect tissue oxygenation data via hyperspectral imaging before and after endovascular procedures.

Detailed Description

This will be a nonrandomized, nonblinded, prospective observational study to correlate the results obtained with the traditional measures of success of endovascular revascularization of peripheral arteries for the treatment of chronic limb ischemia; i.e., ABPI, PVR with oxyhemoglobin (OxyHb) and deoxyhemoglobin (DeoxyHb) measurements obtained with a new imaging device manufactured by HyperMed Inc (OxyVu) that uses hyperspectral technology.

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

60Estimated

Label	Type	Description	Intervention Names
One Cohort

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with established diagnosis of lower limb ischemic based on their symptoms of claudication, rest pain, non-healing ulcers or gangrene and other vascular laboratory tests that are currently used to make this diagnosis and have been scheduled for endovascular revascularization.
Age group between 50-85
Gender - Male or Female
Race - all race and ethnicities

Exclusion Criteria:

Patients with known cardiac disease - new MI (within 3 months).
Patients with hypertension with the systolic BP >200 or diastolic BP>110 on the day of testing
Patients on supplemental O2 for chronic obstructive lung disease
Bed-ridden subjects - either due to chronic disability or neurological problems

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who have chronic limb ischemia and present with the symptoms of claudication, rest pain or having minor non-healing ulcers or gangrene (Rutherford category 1 to 6) who also require percutaneous endovascular revascularization.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kevin Scomacker, PhD	Contact	781-229-5900		kschomacker@hypermed-inc.com

Overall Officials

Name	Affiliation	Role
Kevin Schomacker, PhD	HyperMed	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardiac, Vascular & Thoracic Surgery Associates	Recruiting	Falls Church	Virginia	22042	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17397438	Background	Ostchega Y, Paulose-Ram R, Dillon CF, Gu Q, Hughes JP. Prevalence of peripheral arterial disease and risk factors in persons aged 60 and older: data from the National Health and Nutrition Examination Survey 1999-2004. J Am Geriatr Soc. 2007 Apr;55(4):583-9. doi: 10.1111/j.1532-5415.2007.01123.x.
17377162	Background

ID	Term
D058729	Peripheral Arterial Disease
D016491	Peripheral Vascular Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases