NCT02578667

Gorbly Compression Device for Use in Image-guided Procedures

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasm
• Sepsis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2015-10-19
• Last updated: 2016-05-17

Locations

1 site across 1 country: United States