Gorbly Compression Device for Use in Image-guided Procedures

Sepsis Clinical Trial

Official title:

Gorbly Compression Device for Use in Image-guided Procedures

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02578667
• Other study ID #: 20150294
• Status: Not yet recruiting
• Phase: N/A
• First received: October 7, 2015
• Last updated: October 15, 2015
• Start date: December 2015
• Est. completion date: November 2016

Study information

• Verified date: October 2015
• Source: University of Miami
• Contact: Issam Kably, MD
• Phone: 3055856894
• Email: ikably[@]med.miami.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Prospective cohort study. All patients presenting for percutaneous abdomino-pelvic soft tissue ablation, biopsy, or drainage performed under the care of Dr. Issam Kably will become part of the study population. Based on prior imaging and/or imaging at the time of the procedure, patients will fall into two groups, those for whom no compression is necessary to complete the procedure and those for whom compression may provide benefit. These would be selected based on Dr. Kably's experience as a practicing academic, fellowship-trained, and CAQ'ed interventional radiologist. The latter group would then further subdivide into those who give consent for use of the compression device and those who do not consent. Results of each group would be measured including the following: termination versus successful completion of the procedure; adverse events including bleeding or damage to surrounding structures necessitating further medical or surgical intervention.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: November 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All-comers presenting for percutaneous abdomino-pelvic soft tissue ablation, biopsy, or drainage .

Exclusion Criteria:

• Open surgical or traumatic abdominal wall.

• Active abdominal wall infection.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Neoplasm
• Sepsis

Intervention

Device:
• Gorbly Compression Device
The compression device provides a way to displace critical structures along the path from skin to target, retract excess body wall tissue, and provide mechanical stabilization in a repeatable and sustainable fashion.

Locations

Country	Name	City	State
United States	Jackson Memorial Hospital	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Wallace H Coulter Center for Translational Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of procedures (i.e., ablations, biopsies, or drainages) that are allowed successful completion.		intraoperative	No
Secondary	The rate of complication of bleeding or damage to the surrounding vessels or organs by use of the compression device.		intraoperative	Yes