Pilot Study Differential Dissector™ for Blunt Dissection | NCT02382952

Studies
Pilot Study Differential Dissector™ for Blunt Dissection

NCT02382952

Sponsor

University of North Carolina, Chapel Hill

Status

Withdrawn

Last Update Posted

Aug 5, 2016Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Surgical Adhesions
Blood Loss, Surgical

Interventions

Differential Dissector
Standard Dissection Method

Countries

Not provided

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

Jul 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Jul 2016Estimated

Completion Date

Jul 2016Estimated

First Submitted Date

Mar 3, 2015

First Submission Date that Met QC Criteria

Mar 3, 2015

First Posted Date

Mar 9, 2015Estimated

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

Aug 3, 2016

Last Update Posted Date

Aug 5, 2016Estimated

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

The primary purpose of this study is to evaluate the quality of blunt dissection during abdominal and pelvic surgery involving dissection of adhesions, separation of blood vessels and neurovascular structures while preserving the integrity of these structures.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Differential Dissector	Experimental	For patients in the study device group, blunt dissection will be performed with the Differential Dissector whenever the surgeon believes its use is appropriate.	Device: Differential Dissector
Standard Dissection Method	Active Comparator	For patients in the control group, blunt dissection will be performed by standard method.	Other: Standard Dissection Method

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Differential Dissector	Device		Differential Dissector
Standard Dissection Method

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Operative Blood Loss		From start of surgery to wound closure
Post-operative Blood Loss		After surgical closure and drain insertion through drain removal

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age greater than 18
Patient will be undergoing open abdominal surgery
Patient willing and able to provide his/her own consent

Exclusion Criteria:

Current alcohol or other substance abuse
Current incarceration

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
Mark Koruda, MD	University of North Carolina, Chapel Hill	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000267	Tissue Adhesions
D016063	Blood Loss, Surgical

Ancestor Terms

ID	Term
D002921	Cicatrix
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided