NeoplasmNCT02578667
Gorbly Compression Device for Use in Image-guided Procedures
A study testing Gorbly Compression Device in people with Neoplasm and Sepsis, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Gorbly Compression Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All-comers presenting for percutaneous abdomino-pelvic soft tissue ablation, biopsy, or drainage .
Who cannot join
- Open surgical or traumatic abdominal wall.
- Active abdominal wall infection.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Gorbly Compression Device
- Medical subject headings
- Neoplasms, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gorbly Compression DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Gorbly Compression not needed | No intervention | Not described |
| Gorbly Compression may benefit | Experimental | the use of the Gorbly device with the consent of the patient Receives: Device: Gorbly Compression Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of procedures (i.e., ablations, biopsies, or drainages) that are allowed successful completion.
Measured: intraoperative
Secondary outcomes (1)
The rate of complication of bleeding or damage to the surrounding vessels or organs by use of the compression device.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startDec 2015
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: study cancelled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Wallace H Coulter Center for Translational Research
- Responsible party
- Principal investigator, Issam Kably, University of Miami
- Investigators
- Issam Kably, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578667
- Sponsor's protocol ID
- 20150294
- Status last verified
- May 2016
- First submitted
- 7 Oct 2015
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gorbly Compression Device for Use in Image-guided Procedures
- ClinicalTrials.gov ID
- NCT02578667
- Acronym / sponsor ID
- 20150294
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study cancelled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Wallace H Coulter Center for Translational Research
- Study start
- Dec 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 19 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gorbly Compression not needed | No intervention | – |
| Gorbly Compression may benefit | Experimental | Device: Gorbly Compression Devicethe use of the Gorbly device with the consent of the patient |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All-comers presenting for percutaneous abdomino-pelvic soft tissue ablation, biopsy, or drainage .
Key exclusion criteria (2 listed)
- Open surgical or traumatic abdominal wall.
- Active abdominal wall infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gorbly Compression DeviceThe 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. | Device | Gorbly Compression may benefit |
Primary outcome
The percentage of procedures (i.e., ablations, biopsies, or drainages) that are allowed successful completion.
Time frame: intraoperative
1 secondary outcome
The rate of complication of bleeding or damage to the surrounding vessels or organs by use of the compression device.
Time frame: intraoperative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Issam Kably, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gorbly Compression Device in people with Neoplasm and Sepsis, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of procedures (i.e., ablations, biopsies, or drainages) that are allowed successful completion. (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2016.