Gorbly Compression Device for Use in Image-guided Procedures | NCT02578667

Studies
Gorbly Compression Device for Use in Image-guided Procedures

NCT02578667

Sponsor

University of Miami

Status

Withdrawn

Last Update Posted

May 17, 2016Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Neoplasm
Sepsis

Interventions

Gorbly Compression Device

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

study cancelled

Expanded Access Info

Start Date

Dec 2015

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Oct 7, 2015

First Submission Date that Met QC Criteria

Oct 15, 2015

First Posted Date

Oct 19, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2016

Last Update Posted Date

May 17, 2016Estimated

Name	Class
Wallace H Coulter Center for Translational Research	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
The rate of complication of bleeding or damage to the surrounding vessels or organs by use of the compression device.		intraoperative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Issam Kably, MD	University of Miami	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jackson Memorial Hospital		Miami	Florida	33136	United States

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D018805	Sepsis

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided