Pilot Study Differential Dissector™ for Blunt Dissection

Blood Loss, Surgical Clinical Trial

Official title:

Pilot Study Differential Dissector™ for Blunt Dissection

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02382952
• Other study ID #: 14-2888
• Status: Withdrawn
• Phase: N/A
• First received: March 3, 2015
• Last updated: August 3, 2016
• Start date: March 2015
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Surgical Adhesions
• Tissue Adhesions

Intervention

Device:
• Differential Dissector

Other:
• Standard Dissection Method

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative Blood Loss		From start of surgery to wound closure	No
Primary	Post-operative Blood Loss		After surgical closure and drain insertion through drain removal	No