Subglottic Stenosis (SGS)NCT07303673
Coblation Assisted Dilatation Versus Modified Maddern Procedure in Subglottic and Cervical Tracheal Stenosis
A study testing Coblation-assisted dilatation and Modified Maddern procedure in people with Subglottic Stenosis (SGS), run by Mansoura University at 1 site in Egypt.
Trial summary
This study compares the effectiveness of Coblation-assisted endoscopic airway dilatation with the modified Maddern procedure-which involves endoscopic excision of scar tissue followed by buccal mucosal grafting-in patients with subglottic and/or upper tracheal stenosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Subglottic Stenosis (SGS)
- What is being tested?
- Coblation-assisted dilatation and Modified Maddern procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 1 Dec 2025
- 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 consecutive patients with (grade II, III) subglottic and/or upper tracheal stenosis according to Myer-Cotton grading system
- all age groups (children and adults)
Who cannot join
- Patients with cervical spine diseases where an extended position during the procedure could be problematic.
- Previous neck or oral cavity irradiation.
- chronic uncontrolled debilitating diseases that might interfere with the healing process e.g. (diabetes mellitus, renal failure, decompensated liver diseases).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine, Mansoura University
Al Mansurah, Dakahlia Governorate, 35511
About this study
Official title: Coblation Assisted Dilatation Versus Modified Maddern Procedure in Subglottic and Cervical Tracheal Stenosis: a Randomized Clinical Trial
This study compares the effectiveness of Coblation-assisted endoscopic airway dilatation with the modified Maddern procedure-which involves endoscopic excision of scar tissue followed by buccal mucosal grafting-in patients with subglottic and/or upper tracheal stenosis.
- Conditions
- Subglottic Stenosis (SGS)
- Being tested
- Coblation-assisted dilatation, Modified Maddern procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coblation-assisted dilatationProcedure or surgery
endoscopic Coblation-assisted dilatation is done for subglottic and / or upper tracheal stenosis. Radial incisions are done using the coblation technique, followed by balloon dilatation.
Modified Maddern procedureProcedure or surgery
endoscopic excision of the scar tissue is done in patients with subglottic and / or upper tracheal stenosis. The resultant raw surface is covered with a buccal mucosal graft harvested from the patient cheek mucosa. The donor site is closed by primary suturing.
| Study group | Role | What they receive |
|---|---|---|
| Coblation-assisted dilatation group | Active comparator | Not described Receives: Procedure: Coblation-assisted dilatation |
| Modified Maddern procedure group | Active comparator | Not described Receives: Procedure: Modified Maddern procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway diameter
assessment of the diameter of the airway after the procedure by endoscopic examination
Measured: 3, 6, and 12 weeks
Secondary outcomes (1)
subjective evaluation of breathing
the breathing is evaluated subjectively using the dyspnea handicap index. The Dyspnea Handicap Index (DHI) is a validated self-reported questionnaire consisting of 10 items, each scored as 0 (never), 2 (sometimes), or 4 (always), yielding a total score from 0 to 40, with higher scores indicating greater severity of dyspnea-related functional and emotional handicap.
Measured: 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start1 Jun 2024
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Subglottic Stenosis (SGS)Studies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303673
- Sponsor's protocol ID
- MD.24.05.858
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kavookjian, H., & Hillel, A. (2023). Endoscopic laryngotracheoplasty (Maddern procedure) for idiopathic subglottic stenosis. Operative Techniques in Otolaryngology-Head and Neck Surgery, 34(2), 115-119.
Pasick LJ, Anis MM, Rosow DE. An Updated Review of Subglottic Stenosis: Etiology, Evaluation, and Management. Curr Pulmonol Rep. 2022;11(2):29-38. doi: 10.1007/s13665-022-00286-6. Epub 2022 Mar 3.
PubMed 35261874Wijermars LGM, Hoekstra CEL, Nguyen TTT, Stevens MF, Dikkers FG. New Treatment Strategy for Subglottic Stenosis Using the Trachealator, a Novel Non-occlusive Balloon. Laryngoscope. 2022 Nov;132(11):2202-2205. doi: 10.1002/lary.30234. Epub 2022 May 30. No abstract available.
PubMed 35634800Lorenz RR. The Evolution and Outcomes of the "Maddern Procedure" for the Treatment of Subglottic Stenosis. Laryngoscope. 2023 Nov;133(11):3100-3108. doi: 10.1002/lary.30752. Epub 2023 May 17.
PubMed 37194674
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coblation Assisted Dilatation Versus Modified Maddern Procedure in Subglottic and Cervical Tracheal Stenosis: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07303673
- Acronym / sponsor ID
- MD.24.05.858
- Conditions
- Subglottic Stenosis (SGS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 26 Dec 2025 (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 effectiveness of Coblation-assisted endoscopic airway dilatation with the modified Maddern procedure-which involves endoscopic excision of scar tissue followed by buccal mucosal grafting-in patients with subglottic and/or upper tracheal stenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coblation-assisted dilatation group | Active comparator | Procedure: Coblation-assisted dilatation |
| Modified Maddern procedure group | Active comparator | Procedure: Modified Maddern procedure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All consecutive patients with (grade II, III) subglottic and/or upper tracheal stenosis according to Myer-Cotton grading system
- all age groups (children and adults)
Key exclusion criteria (3 listed)
- Patients with cervical spine diseases where an extended position during the procedure could be problematic.
- Previous neck or oral cavity irradiation.
- chronic uncontrolled debilitating diseases that might interfere with the healing process e.g. (diabetes mellitus, renal failure, decompensated liver diseases).
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 |
|---|---|---|
| Coblation-assisted dilatationendoscopic Coblation-assisted dilatation is done for subglottic and / or upper tracheal stenosis. Radial incisions are done using the coblation technique, followed by balloon dilatation. | Procedure or surgery | Coblation-assisted dilatation group |
| Modified Maddern procedureendoscopic excision of the scar tissue is done in patients with subglottic and / or upper tracheal stenosis. The resultant raw surface is covered with a buccal mucosal graft harvested from the patient cheek mucosa. The donor site is closed by primary suturing. | Procedure or surgery | Modified Maddern procedure group |
Primary outcome
Airway diameter
Time frame: 3, 6, and 12 weeks
assessment of the diameter of the airway after the procedure by endoscopic examination
1 secondary outcome
subjective evaluation of breathing
Time frame: 3, 6, and 12 months
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 26 Dec 2025.
- Results publicationKavookjian, H., & Hillel, A. (2023). Endoscopic laryngotracheoplasty (Maddern procedure) for idiopathic subglottic stenosis. Operative Techniques in Otolaryngology-Head and Neck Surgery, 34(2), 115-119.
- Results publication: PubMed 35261874Pasick LJ, Anis MM, Rosow DE. An Updated Review of Subglottic Stenosis: Etiology, Evaluation, and Management. Curr Pulmonol Rep. 2022;11(2):29-38. doi: 10.1007/s13665-022-00286-6. Epub 2022 Mar 3.
- Results publication: PubMed 35634800Wijermars LGM, Hoekstra CEL, Nguyen TTT, Stevens MF, Dikkers FG. New Treatment Strategy for Subglottic Stenosis Using the Trachealator, a Novel Non-occlusive Balloon. Laryngoscope. 2022 Nov;132(11):2202-2205. doi: 10.1002/lary.30234. Epub 2022 May 30. No abstract available.
- Results publication: PubMed 37194674Lorenz RR. The Evolution and Outcomes of the "Maddern Procedure" for the Treatment of Subglottic Stenosis. Laryngoscope. 2023 Nov;133(11):3100-3108. doi: 10.1002/lary.30752. Epub 2023 May 17.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coblation-assisted dilatation and Modified Maddern procedure in people with Subglottic Stenosis (SGS), run by Mansoura 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 2 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: finished, as of the sponsor's last update on 26 Dec 2025. 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?
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.
What does the primary outcome measure?
Airway diameter (time frame: 3, 6, and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07303673, which also lists 4 linked publications.
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 26 Dec 2025.