Nasal Perforated SeptumNCT06439927
New Method to Close Nasal Septal Perforation
A study testing Polycaprolactone nasal mesh in people with Nasal Perforated Septum, run by Helwan University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to investigate if a 3-dimensional fabricated nasal mesh works to close nasal septal perforations. Under general anesthesia, during nasal septal perforation repair surgery, the investigator will place the mesh between the elevated mucoperichondrial flaps opposite the site of the… Read more about this study
- Who is it for?
- Ages 18 to 58 years
- Conditions the study is for
- Nasal Perforated Septum
- What is being tested?
- Polycaprolactone nasal mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 58 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing nasal septal perforation repair surgery.
Who cannot join
- Patients with known allergy to polycaprolactone.
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Helwan University
Cairo
Mohamed H Sebaey, master degree, 01008306356, mohamed.h757@hotmail.com
About this study
Official title: Nasal Septal Perforation Closure Using a 3-dimensional Fabricated Polycaprolactone Nasal Mesh
The goal of this clinical trial is to investigate if a 3-dimensional fabricated nasal mesh works to close nasal septal perforations. Under general anesthesia, during nasal septal perforation repair surgery, the investigator will place the mesh between the elevated mucoperichondrial flaps opposite the site of the perforation and confirm its original position at both sides under nasal endoscope. Endoscopic examination for septal mucosa status will be done monthly for a three months follow up period.
- Conditions
- Nasal Perforated Septum
- Being tested
- Polycaprolactone nasal mesh
- Keywords
- nasal septal perforation
- Medical subject headings
- Nasal Septal Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polycaprolactone nasal meshDevice
a 3-dimensional fabricated Polycaprolactone nasal mesh
| Study group | Role | What they receive |
|---|---|---|
| Polycaprolactone nasal mesh | Experimental | Not described Receives: Device: Polycaprolactone nasal mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Post-operative healing of septal perforation
Endoscopic evaluation of nasal septal mucosa status will be classified as complete bilateral healing, complete unilateral healing, no healing, and perforation.
Measured: for a three months follow up period
Secondary outcomes (1)
Postoperative complications
The following complications will be evaluated on a present/absent basis:hematoma-infection-allergy
Measured: for a three months follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start1 Aug 2024
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal Perforated SeptumStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hossam Sebaey, Helwan University
- Investigators
- Mohamed H Sebaey, master degree, Principal investigator, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439927
- Sponsor's protocol ID
- self sponsored
- Status last verified
- Nov 2024
- First submitted
- 28 May 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Septal Perforation Closure Using a 3-dimensional Fabricated Polycaprolactone Nasal Mesh
- ClinicalTrials.gov ID
- NCT06439927
- Acronym / sponsor ID
- self sponsored
- Conditions
- Nasal Perforated Septum
- Keywords
- nasal septal perforation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 Jun 2024 (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.
The goal of this clinical trial is to investigate if a 3-dimensional fabricated nasal mesh works to close nasal septal perforations. Under general anesthesia, during nasal septal perforation repair surgery, the investigator will place the mesh between the elevated mucoperichondrial flaps opposite the site of the perforation and confirm its original position at both sides under nasal endoscope. Endoscopic examination for septal mucosa status will be done monthly for a three months follow up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polycaprolactone nasal mesh | Experimental | Device: Polycaprolactone nasal mesh |
Who may qualify
- Ages
- 18 to 58 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients undergoing nasal septal perforation repair surgery.
Key exclusion criteria (2 listed)
- Patients with known allergy to polycaprolactone.
- Pregnancy or lactation.
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 |
|---|---|---|
| Polycaprolactone nasal mesha 3-dimensional fabricated Polycaprolactone nasal mesh | Device | Polycaprolactone nasal mesh |
Primary outcome
Mean Change in Post-operative healing of septal perforation
Time frame: for a three months follow up period
Endoscopic evaluation of nasal septal mucosa status will be classified as complete bilateral healing, complete unilateral healing, no healing, and perforation.
1 secondary outcome
Postoperative complications
Time frame: for a three months follow up period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: No
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.
Mohamed H Sebaey, master degree principal investigator
Helwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polycaprolactone nasal mesh in people with Nasal Perforated Septum, run by Helwan University at 1 site in Egypt.
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: looking for participants now, as of the sponsor's last update on 5 Nov 2024. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed H Sebaey, Master degree (01008306356, mohamed.h757@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Post-operative healing of septal perforation (time frame: for a three months follow up period). 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 Nov 2024; AzTrials last refreshed its copy on 27 Oct 2026.