Surgical AdhesionsNCT02382952
Pilot Study Differential Dissector™ for Blunt Dissection
A study testing Differential Dissector and Standard Dissection Method in people with Surgical Adhesions and Blood Loss, Surgical, run by University of North Carolina, Chapel Hill.
Trial summary
The primary purpose of this study is to evaluate the quality of blunt dissection during abdominal and pelvic surgery involving dissection of adhesions, separation of blood vessels and neurovascular structures while preserving the integrity of these structures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Adhesions, Blood Loss, Surgical
- What is being tested?
- Differential Dissector and Standard Dissection Method
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18
- Patient will be undergoing open abdominal surgery
- Patient willing and able to provide his/her own consent
Who cannot join
- Current alcohol or other substance abuse
- Current incarceration
About this study
The primary purpose of this study is to evaluate the quality of blunt dissection during abdominal and pelvic surgery involving dissection of adhesions, separation of blood vessels and neurovascular structures while preserving the integrity of these structures.
- Conditions
- Surgical Adhesions, Blood Loss, Surgical
- Being tested
- Differential Dissector, Standard Dissection Method
- Keywords
- Abdominal surgery, Pelvic surgery, Stoma takedown, Bowel resection, Lysis of abdominal adhesions
- Medical subject headings
- Tissue Adhesions, Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Differential DissectorDevice
Standard Dissection MethodOther
| Study group | Role | What they receive |
|---|---|---|
| Differential Dissector | Experimental | For patients in the study device group, blunt dissection will be performed with the Differential Dissector whenever the surgeon believes its use is appropriate. Receives: Device: Differential Dissector |
| Standard Dissection Method | Active comparator | For patients in the control group, blunt dissection will be performed by standard method. Receives: Other: Standard Dissection Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Blood Loss
Measured: From start of surgery to wound closure
Post-operative Blood Loss
Measured: After surgical closure and drain insertion through drain removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical AdhesionsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Koruda, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382952
- Sponsor's protocol ID
- 14-2888
- Status last verified
- Jul 2016
- First submitted
- 3 Mar 2015
- Last updated
- 5 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Differential Dissector™ for Blunt Dissection
- ClinicalTrials.gov ID
- NCT02382952
- Acronym / sponsor ID
- 14-2888
- Conditions
- Surgical Adhesions, Blood Loss, Surgical
- Keywords
- Abdominal surgery, Pelvic surgery, Stoma takedown, Bowel resection, Lysis of abdominal adhesions
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 9 Mar 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.
The primary purpose of this study is to evaluate the quality of blunt dissection during abdominal and pelvic surgery involving dissection of adhesions, separation of blood vessels and neurovascular structures while preserving the integrity of these structures.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Differential Dissector | Experimental | Device: Differential DissectorFor patients in the study device group, blunt dissection will be performed with the Differential Dissector whenever the surgeon believes its use is appropriate. |
| Standard Dissection Method | Active comparator | Other: Standard Dissection MethodFor patients in the control group, blunt dissection will be performed by standard method. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than 18
- Patient will be undergoing open abdominal surgery
- Patient willing and able to provide his/her own consent
Key exclusion criteria (2 listed)
- Current alcohol or other substance abuse
- Current incarceration
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 |
|---|---|---|
| Differential Dissector | Device | Differential Dissector |
| Standard Dissection Method | Other | Standard Dissection Method |
Primary outcome
Operative Blood Loss
Time frame: From start of surgery to wound closure
Post-operative Blood Loss
Time frame: After surgical closure and drain insertion through drain removal
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 5 Aug 2016.
- Individual participant dataSharing planned: No
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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.
Mark Koruda, MD principal investigator
University of North Carolina, Chapel Hill
Questions about this trial
What is this clinical trial studying?
A study testing Differential Dissector and Standard Dissection Method in people with Surgical Adhesions and Blood Loss, Surgical, run by University of North Carolina, Chapel Hill.
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 3 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 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Operative Blood Loss (time frame: From start of surgery to wound closure). The study lists 2 primary outcomes in all. 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 5 Aug 2016.