AdhesionNCT05415059
LEAFix Adhesion in Healthy Volunteers
A study testing Covatech Stoma bag material in people with Adhesion, run by Liverpool University Hospitals NHS Foundation Trust.
Trial summary
This study compares the adhesiveness of the 3M material to be used in the final design. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Adhesion
- What is being tested?
- Covatech Stoma bag material
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2022to Nov 2022
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Not been in a trial in last 12 weeks
- mild to no skin issues
Who cannot join
- any significant allergies
- any allergies to skin adhesive
- any medium to severe skin issues
About this study
Official title: Laryngeal, Endotracheal Airway Fixator (LEAFix): In Vivo Skin Adhesion Verification Protocol
This study compares the adhesiveness of the 3M material to be used in the final design.
Read the detailed description
The material is taken from a CE marked stoma bag. Strips will be placed on to healthy volunteers on the arm and face for 10 minutes and 24 hours. A force gauge will measure the peel force. This will be compared to previous testing on metal.
Participants will also be assessed and followed up for any adverse skin issues.
- Conditions
- Adhesion
- Being tested
- Covatech Stoma bag material
- Medical subject headings
- Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covatech Stoma bag materialDevice
Strips of Covatech Stoma bag used to asses adhesion of 3M material to be used in LEAFix device
| Study group | Role | What they receive |
|---|---|---|
| Main Cohort | Other | Cohort of healthy volunteers to have device affixed Receives: Device: Covatech Stoma bag material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adhesion after 24 hours
Adhesion after 24 hours of placement inferred from peel force measured with a force gauge at 10 minutes and 24 hours measured in Newtons (N)
Measured: 24 hours
Secondary outcomes (1)
Skin outcomes
Asses for any issues with adhesion to the skin with a questionnaire on day 7 - likehart scale for different skin parameters ie. degree of itchiness with 0 being none and 3 being severe
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start10 Aug 2022 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdhesionStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415059
- Sponsor's protocol ID
- SP0935
- Status last verified
- Mar 2022
- First submitted
- 1 Jun 2022
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For internal use
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laryngeal, Endotracheal Airway Fixator (LEAFix): In Vivo Skin Adhesion Verification Protocol
- ClinicalTrials.gov ID
- NCT05415059
- Acronym / sponsor ID
- SP0935
- Conditions
- Adhesion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Study start
- 10 Aug 2022 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 10 Jun 2022 (actual)
- 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.
This study compares the adhesiveness of the 3M material to be used in the final design.
Detailed description
The material is taken from a CE marked stoma bag. Strips will be placed on to healthy volunteers on the arm and face for 10 minutes and 24 hours. A force gauge will measure the peel force. This will be compared to previous testing on metal.
Participants will also be assessed and followed up for any adverse skin issues.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main Cohort | Other | Device: Covatech Stoma bag materialCohort of healthy volunteers to have device affixed |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy volunteers
- Not been in a trial in last 12 weeks
- mild to no skin issues
Key exclusion criteria (3 listed)
- any significant allergies
- any allergies to skin adhesive
- any medium to severe skin issues
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 |
|---|---|---|
| Covatech Stoma bag materialStrips of Covatech Stoma bag used to asses adhesion of 3M material to be used in LEAFix device | Device | Main Cohort |
Primary outcome
Adhesion after 24 hours
Time frame: 24 hours
Adhesion after 24 hours of placement inferred from peel force measured with a force gauge at 10 minutes and 24 hours measured in Newtons (N)
1 secondary outcome
Skin outcomes
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Individual participant dataSharing planned: No. For internal use
Related trials for Adhesion
Enrolling by invitationObservational study
Intestinal Obstruction Surgery. Acute Abdominal Pathology. №9:05/05/2026
Small Bowel Adhesion, Obstruction Bowel
Recruiting
Ultrasound-Guided Repeated Saline Injections to Prevent and Treat Tendon Adhesions After Hand Tendon Repair
Tendon Adhesion, Zone II Flexor Tendon Injury
RecruitingObservational study
Comparison of Operative Hysteroscopy and Vacuum Aspiration for Terminating First-trimester Pregnancy With Intrauterine Adhesions
Pregnancy Complicated With Intrauterine Adhesion
RecruitingObservational study
Evaluation of Patients With Immune Function Abnormalities
Chronic Granulomatous Disease (CGD), X-Linked Severe Combined Immune Deficiency (XSCID)
RecruitingObservational study
3D MRE-Based Evaluation of Vestibular Schwannoma Mechanical Properties and Histological Features
Vestibular Schwannoma
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Covatech Stoma bag material in people with Adhesion, run by Liverpool University Hospitals NHS Foundation Trust.
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 3 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: status not confirmed, as of the sponsor's last update on 8 Aug 2022. 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?
Results are not available in the source record.
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?
Adhesion after 24 hours (time frame: 24 hours). 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 8 Aug 2022.