Gorbly Compression Device for Use in Image-guided Procedures

NCT02578667 | Withdrawn

• 1 other identifier: 20150294
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasm; Sepsis

Outcome Measures

Primary Outcomes (1)

• The percentage of procedures (i.e., ablations, biopsies, or drainages) that are allowed successful completion.

  intraoperative

Secondary Outcomes (1)

• The rate of complication of bleeding or damage to the surrounding vessels or organs by use of the compression device.

  intraoperative

Study Arms (2)

Gorbly Compression not needed

NO INTERVENTION

Gorbly Compression may benefit

EXPERIMENTAL

the use of the Gorbly device with the consent of the patient

Device: Gorbly Compression Device

Interventions

Gorbly Compression Device 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.

Gorbly Compression may benefit

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Open surgical or traumatic abdominal wall.
• Active abdominal wall infection.

Sponsors & Collaborators

• University of Miami: lead
• Wallace H Coulter Center for Translational Research: collaborator

Study Sites (1)

Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Neoplasms; Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Issam Kably, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: October 19, 2015
• Study Start: December 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: May 17, 2016

Record last verified: 2016-05

Locations

US (1)