Gorbly Compression Device for Use in Image-guided Procedures

• Sponsor: University of Miami (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02578667
• Collaborator: Wallace H Coulter Center for Translational Research (Other)
• Enrollment: 0
• Location: 1
• Arms: 2
• Duration (Months): 1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasm; Sepsis	Device: Gorbly Compression Device	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Official Title: Gorbly Compression Device for Use in Image-guided Procedures
• Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Gorbly Compression not needed
Experimental: Gorbly Compression may benefit the use of the Gorbly device with the consent of the patient	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.

Outcome Measures

Primary Outcome Measures

1. The percentage of procedures (i.e., ablations, biopsies, or drainages) that are allowed successful completion. [intraoperative]

Secondary Outcome Measures

1. The rate of complication of bleeding or damage to the surrounding vessels or organs by use of the compression device. [intraoperative]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jackson Memorial Hospital	Miami	Florida	United States	33136

Sponsors and Collaborators

• University of Miami
• Wallace H Coulter Center for Translational Research

Investigators

• Principal Investigator: Issam Kably, MD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Issam Kably, Assistant Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT02578667
• Other Study ID Numbers: 20150294
• First Posted: Oct 19, 2015
• Last Update Posted: May 17, 2016
• Last Verified: May 1, 2016

Study Results

No Results Posted as of May 17, 2016