Neoplasm, Sepsis
Conditions
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.
Interventions
DEVICEGorbly 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.
Sponsors
Wallace H Coulter Center for Translational Research
University of Miami
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of procedures (i.e., ablations, biopsies, or drainages) that are allowed successful completion. | intraoperative |
Secondary
| Measure | Time frame |
|---|---|
| The rate of complication of bleeding or damage to the surrounding vessels or organs by use of the compression device. | intraoperative |
Countries
United States
Outcome results
None listed