Pilot Study Differential Dissector™ for Blunt Dissection

NCT ID: NCT02382952

Last Updated: 2016-08-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-07-31

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.

Conditions

Surgical Adhesions; Blood Loss, Surgical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Differential Dissector

For patients in the study device group, blunt dissection will be performed with the Differential Dissector whenever the surgeon believes its use is appropriate.

Group Type: EXPERIMENTAL

Differential Dissector

Intervention Type: DEVICE

Standard Dissection Method

For patients in the control group, blunt dissection will be performed by standard method.

Group Type: ACTIVE_COMPARATOR

Standard Dissection Method

Intervention Type: OTHER

Interventions

Differential Dissector

Intervention Type: DEVICE

Standard Dissection Method

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Koruda, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Other Identifiers

14-2888

Identifier Type: -

Identifier Source: org_study_id