Tissue BreakdownNCT00395980
Muscle Pressure in the Flank Position
A study testing surgical table pressure mat in people with Tissue Breakdown, run by University of California, Irvine at 1 site in United States.
Trial summary
Using healthy volunteers, participants will lay on an operating room table in various positions employed during kidney surgery. Using a pressure sensor mat, we hope to determine which areas of the body are subject to higher pressures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tissue Breakdown
- What is being tested?
- surgical table pressure mat
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Jul 2007
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Subjects with musculoskeletal disabilities
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine Medical Center
Orange, California, 92868
About this study
Using healthy volunteers, participants will lay on an operating room table in various positions employed during kidney surgery. Using a pressure sensor mat, we hope to determine which areas of the body are subject to higher pressures. Using padding devices (foam, gel, water mattress)which are currently used in the operating room will be employed and measurements will be taken to determine which padding material and configurations is optimal to reduce the pressure to those body parts at risk for excessive pressure subject during laparoscopic surgery.
- Conditions
- Tissue Breakdown
- Being tested
- surgical table pressure mat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical table pressure matDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2006 (estimated)
- Study startOct 2006
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tissue BreakdownStudies 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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Investigators
- Leslie A. Deane, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00395980
- Sponsor's protocol ID
- 2006-5106
- Status last verified
- Dec 2008
- First submitted
- 2 Nov 2006
- Last updated
- 12 Dec 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Pressure in the Flank Position
- ClinicalTrials.gov ID
- NCT00395980
- Acronym / sponsor ID
- 2006-5106
- Conditions
- Tissue Breakdown
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Oct 2006
- Study completion
- Jul 2007 (actual)
- First posted
- 6 Nov 2006 (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.
Using healthy volunteers, participants will lay on an operating room table in various positions employed during kidney surgery. Using a pressure sensor mat, we hope to determine which areas of the body are subject to higher pressures. Using padding devices (foam, gel, water mattress)which are currently used in the operating room will be employed and measurements will be taken to determine which padding material and configurations is optimal to reduce the pressure to those body parts at risk for excessive pressure subject during laparoscopic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Subjects with musculoskeletal disabilities
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 |
|---|---|---|
| surgical table pressure mat | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2008.
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.
Leslie A. Deane, MD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgical table pressure mat in people with Tissue Breakdown, run by University of California, Irvine 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 0 inclusion and 1 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: finished, as of the sponsor's last update on 12 Dec 2008. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 12 Dec 2008; AzTrials last refreshed its copy on 31 Oct 2026.