Gorbly Compression Device for Use in Image-guided Procedures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Neoplasm Sepsis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Gorbly Compression not needed

Group Type NO_INTERVENTION

No interventions assigned to this group

Gorbly Compression may benefit

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

Group Type EXPERIMENTAL

Gorbly Compression Device

Intervention Type 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.

Interventions

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