Gorbly Compression Device for Use in Image-guided Procedures

University of Miami

Status: Withdrawn

Conditions: Neoplasm; Sepsis

Treatments: Device: Gorbly Compression Device

Study type: Interventional

Funder types: Other

Identifiers

NCT02578667

20150294

Details and patient eligibility

About

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.

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

0 participants in 2 patient groups

Gorbly Compression not needed

No Intervention group

Gorbly Compression may benefit

Experimental group

Description:

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

Treatment:

Device: Gorbly Compression Device