Gorbly Compression Device for Use in Image-guided Procedures

Not Applicable

Withdrawn

• Conditions: Neoplasm; Sepsis
• Interventions: Device: Gorbly Compression Device

• Registration Number: NCT02578667
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-10-07
• Study First Submitted QC: 2015-10-15
• Study First Posted: 2015-10-19
• Study Start: 2015-12
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-13
• Last Update Posted: 2016-05-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gorbly Compression may benefit	Gorbly Compression Device	the use of the Gorbly device with the consent of the patient

Primary Outcome Measures

Name	Time	Method
The percentage of procedures (i.e., ablations, biopsies, or drainages) that are allowed successful completion.	intraoperative

Secondary Outcome Measures

Name	Time	Method
The rate of complication of bleeding or damage to the surrounding vessels or organs by use of the compression device.	intraoperative

Trial Locations

Locations (1)

Jackson Memorial Hospital; 🇺🇸 Miami, Florida, United States