Choanal AtresiaPhase 4NCT03605537
Use of Mometasone Eluting Stent in Choanal Atresia
A Phase 4 study testing Drug-eluting Stent Mometasone in people with Choanal Atresia, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
This study is to find out how well drug-eluting stents work as part of treatment for choanal atresia repair. Participants will be receiving surgical choanal atresia repair; half will get a drug-eluting stent placed, the other half will not. Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Choanal Atresia
- What is being tested?
- Drug-eluting Stent Mometasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2018to 11 Oct 2019
- Phase
- Phase 4
- 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 Up to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects who are under 11 years old and have a diagnosis of choanal atresia will be included in this study.
Who cannot join
- Those subjects who are 11 years of age or greater or who do not have choanal atresia will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
About this study
This study is to find out how well drug-eluting stents work as part of treatment for choanal atresia repair. Participants will be receiving surgical choanal atresia repair; half will get a drug-eluting stent placed, the other half will not.
Read the detailed description
Objective: To determine the utility of mometasone eluting stents in the treatment of choanal atresia.
Setting: Cincinnati Children's Hospital Medical Center (CCHMC), Division of Pediatric Otolaryngology, Head and Neck Surgery
Study Design: Randomized, single blind control trial
Methods: This study will be a randomized, prospective single-blinded control trial. Inclusion criteria will include all subjects less than 11 years of age who are diagnosed with either unilateral or bilateral choanal atresia. Following enrollment, the patients will be randomized to either a control arm (no stent) versus an intervention arm (placement of drug eluting stent). Subjects will then undergo surgical repair of the choanal atresia with either no stent or a drug eluting stent placed. Multiple postoperative nasal endoscopies will be performed to assess size which will be reviewed and graded by two independent reviewers.
Analysis: Descriptive statistical analysis and multivariate analysis will be performed.
- Conditions
- Choanal Atresia
- Being tested
- Drug-eluting Stent Mometasone
- Medical subject headings
- Choanal Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-eluting Stent MometasoneDrug
Also called Mometasone
The subject will have a mometasone drug-eluting stent placed during their choanal atresia repair procedure instead of no stent being placed.
| Study group | Role | What they receive |
|---|---|---|
| Stent | Experimental | Subjects will undergo repair of the choanal atresia in the operating room with a drug eluting stent placed at the end of the surgical procedure. They will return to the operating room in 3-5 weeks for repeat nasal endoscopy with possible balloon dilation, which is standard of care within our institution. At this time in the operating room the intervention arm will have the stent removed. Following removal of the stent, photodocumentation of the posterior nasal cavity and nasopharynx will take place to assess the size (standard of care).
Subjects will then follow up and undergo a bedside or outpatient nasal endoscopy and nasopharyngoscopy (standard of care) at the following approximate intervals 1 month, 6 months, 12 months (these are not exact time periods as clinic scheduling can sometimes be 2-3 months on either side of these time stamps). Receives: Drug: Drug-eluting Stent Mometasone |
| No Stent | No intervention | Subjects will undergo repair of the choanal atresia in the operating room with no stent placed at the end of the surgical procedure. They will return to the operating room in 3-5 weeks for repeat nasal endoscopy with possible balloon dilation, which is standard of care within our institution. Photodocumentation of the posterior nasal cavity and nasopharynx will take place to assess the size (standard of care). Subjects will then follow up and undergo a bedside or outpatient nasal endoscopy and nasopharyngoscopy (standard of care) at the following approximate intervals 1 month, 6 months, 12 months (these are not exact time periods as clinic scheduling can sometimes be 2-3 months on either side of these time stamps). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Posterior Nasal Cavity
Once photodocumentation from followup visits is collected, the images will be collected by a member of the team and given to two independent expert blinded reviewers for assessment of the size of the posterior nasal cavity. The picture will be obtained from the same anatomical position for each scope (the posterior portion of the inferior turbinate) and compared to the picture immediately after surgery of the posterior nasal cavity to assess any changes in size. Reviewers will assess the size of the posterior nasal cavity in each subsequent scope and categorize subjects based on the following sizes (0-50%, 51-75%, 76-100%).
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start3 Jul 2018
- Primary completion11 Oct 2019
- Study completion11 Oct 2019
Why it stopped: Study terminated due to lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Choanal AtresiaStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Hart, MD, Principal investigator, CCHMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605537
- Sponsor's protocol ID
- 2018-1813
- Status last verified
- Apr 2021
- First submitted
- 20 Jul 2018
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be retained in an identifiable state in a password protected database for potential unspecified research. If this data were to be used in the future, a new IRB would be submitted.
Publications
Deutsch E, Kaufman M, Eilon A. Transnasal endoscopic management of choanal atresia. Int J Pediatr Otorhinolaryngol. 1997 May 4;40(1):19-26. doi: 10.1016/s0165-5876(96)01486-3.
PubMed 9184974Strychowsky JE, Kawai K, Moritz E, Rahbar R, Adil EA. To stent or not to stent? A meta-analysis of endonasal congenital bilateral choanal atresia repair. Laryngoscope. 2016 Jan;126(1):218-27. doi: 10.1002/lary.25393. Epub 2015 May 25.
PubMed 26014684Murr AH, Smith TL, Hwang PH, Bhattacharyya N, Lanier BJ, Stambaugh JW, Mugglin AS. Safety and efficacy of a novel bioabsorbable, steroid-eluting sinus stent. Int Forum Allergy Rhinol. 2011 Jan-Feb;1(1):23-32. doi: 10.1002/alr.20020. Epub 2011 Feb 8.
PubMed 22287304Bangiyev JN, Govil N, Sheyn A, Haupert M, Thottam PJ. Novel Application of Steroid Eluting Stents in Choanal Atresia Repair: A Case Series. Ann Otol Rhinol Laryngol. 2017 Jan;126(1):79-82. doi: 10.1177/0003489416671533. Epub 2016 Oct 7.
PubMed 27913724Wilcox LJ, Smith MM, de Alarcon A, Epperson M, Born H, Hart CK. Use of Steroid-Eluting Stents after Endoscopic Repair of Choanal Atresia: A Case Series with Review. Ann Otol Rhinol Laryngol. 2020 Oct;129(10):1003-1010. doi: 10.1177/0003489420928374. Epub 2020 May 29.
PubMed 32468891Schenkel EJ, Skoner DP, Bronsky EA, Miller SD, Pearlman DS, Rooklin A, Rosen JP, Ruff ME, Vandewalker ML, Wanderer A, Damaraju CV, Nolop KB, Mesarina-Wicki B. Absence of growth retardation in children with perennial allergic rhinitis after one year of treatment with mometasone furoate aqueous nasal spray. Pediatrics. 2000 Feb;105(2):E22. doi: 10.1542/peds.105.2.e22.
PubMed 10654982
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Mometasone Eluting Stent in Choanal Atresia
- ClinicalTrials.gov ID
- NCT03605537
- Acronym / sponsor ID
- 2018-1813
- Conditions
- Choanal Atresia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study terminated due to lack of funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 3 Jul 2018 (actual)
- Primary completion
- 11 Oct 2019 (actual)
- Study completion
- 11 Oct 2019 (actual)
- First posted
- 30 Jul 2018 (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 is to find out how well drug-eluting stents work as part of treatment for choanal atresia repair. Participants will be receiving surgical choanal atresia repair; half will get a drug-eluting stent placed, the other half will not.
Detailed description
Objective: To determine the utility of mometasone eluting stents in the treatment of choanal atresia.
Setting: Cincinnati Children's Hospital Medical Center (CCHMC), Division of Pediatric Otolaryngology, Head and Neck Surgery
Study Design: Randomized, single blind control trial
Methods: This study will be a randomized, prospective single-blinded control trial. Inclusion criteria will include all subjects less than 11 years of age who are diagnosed with either unilateral or bilateral choanal atresia. Following enrollment, the patients will be randomized to either a control arm (no stent) versus an intervention arm (placement of drug eluting stent). Subjects will then undergo surgical repair of the choanal atresia with either no stent or a drug eluting stent placed. Multiple postoperative nasal endoscopies will be performed to assess size which will be reviewed and graded by two independent reviewers.
Analysis: Descriptive statistical analysis and multivariate analysis will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stent | Experimental | Drug: Drug-eluting Stent MometasoneSubjects will undergo repair of the choanal atresia in the operating room with a drug eluting stent placed at the end of the surgical procedure. They will return to the operating room in 3-5 weeks for repeat nasal endoscopy with possible balloon dilation, which is standard of care within our institution. At this time in the operating room the intervention arm will have the stent removed. Following removal of the stent, photodocumentation of the posterior nasal cavity and nasopharynx will take place to assess the size (standard of care). Subjects will then follow up and undergo a bedside or outpatient nasal endoscopy and nasopharyngoscopy (standard of care) at the following approximate intervals 1 month, 6 months, 12 months (these are not exact time periods as clinic scheduling can sometimes be 2-3 months on either side of these time stamps). |
| No Stent | No intervention | –Subjects will undergo repair of the choanal atresia in the operating room with no stent placed at the end of the surgical procedure. They will return to the operating room in 3-5 weeks for repeat nasal endoscopy with possible balloon dilation, which is standard of care within our institution. Photodocumentation of the posterior nasal cavity and nasopharynx will take place to assess the size (standard of care). Subjects will then follow up and undergo a bedside or outpatient nasal endoscopy and nasopharyngoscopy (standard of care) at the following approximate intervals 1 month, 6 months, 12 months (these are not exact time periods as clinic scheduling can sometimes be 2-3 months on either side of these time stamps). |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Subjects who are under 11 years old and have a diagnosis of choanal atresia will be included in this study.
Key exclusion criteria (1 listed)
- Those subjects who are 11 years of age or greater or who do not have choanal atresia will be excluded.
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 |
|---|---|---|
| Drug-eluting Stent MometasoneAlso: MometasoneThe subject will have a mometasone drug-eluting stent placed during their choanal atresia repair procedure instead of no stent being placed. | Drug | Stent |
Primary outcome
Assessment of Posterior Nasal Cavity
Time frame: 12 Months
Once photodocumentation from followup visits is collected, the images will be collected by a member of the team and given to two independent expert blinded reviewers for assessment of the size of the posterior nasal cavity. The picture will be obtained from the same anatomical position for each scope (the posterior portion of the inferior turbinate) and compared to the picture immediately after surgery of the posterior nasal cavity to assess any changes in size. Reviewers will assess the size of the posterior nasal cavity in each subsequent scope and categorize subjects based on the following sizes (0-50%, 51-75%, 76-100%).
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 6 Apr 2021.
- Background: PubMed 9184974Deutsch E, Kaufman M, Eilon A. Transnasal endoscopic management of choanal atresia. Int J Pediatr Otorhinolaryngol. 1997 May 4;40(1):19-26. doi: 10.1016/s0165-5876(96)01486-3.
- Background: PubMed 26014684Strychowsky JE, Kawai K, Moritz E, Rahbar R, Adil EA. To stent or not to stent? A meta-analysis of endonasal congenital bilateral choanal atresia repair. Laryngoscope. 2016 Jan;126(1):218-27. doi: 10.1002/lary.25393. Epub 2015 May 25.
- Background: PubMed 22287304Murr AH, Smith TL, Hwang PH, Bhattacharyya N, Lanier BJ, Stambaugh JW, Mugglin AS. Safety and efficacy of a novel bioabsorbable, steroid-eluting sinus stent. Int Forum Allergy Rhinol. 2011 Jan-Feb;1(1):23-32. doi: 10.1002/alr.20020. Epub 2011 Feb 8.
- Background: PubMed 27913724Bangiyev JN, Govil N, Sheyn A, Haupert M, Thottam PJ. Novel Application of Steroid Eluting Stents in Choanal Atresia Repair: A Case Series. Ann Otol Rhinol Laryngol. 2017 Jan;126(1):79-82. doi: 10.1177/0003489416671533. Epub 2016 Oct 7.
- Background: PubMed 32468891Wilcox LJ, Smith MM, de Alarcon A, Epperson M, Born H, Hart CK. Use of Steroid-Eluting Stents after Endoscopic Repair of Choanal Atresia: A Case Series with Review. Ann Otol Rhinol Laryngol. 2020 Oct;129(10):1003-1010. doi: 10.1177/0003489420928374. Epub 2020 May 29.
- Background: PubMed 10654982Schenkel EJ, Skoner DP, Bronsky EA, Miller SD, Pearlman DS, Rooklin A, Rosen JP, Ruff ME, Vandewalker ML, Wanderer A, Damaraju CV, Nolop KB, Mesarina-Wicki B. Absence of growth retardation in children with perennial allergic rhinitis after one year of treatment with mometasone furoate aqueous nasal spray. Pediatrics. 2000 Feb;105(2):E22. doi: 10.1542/peds.105.2.e22.
- Individual participant dataSharing planned: No. Data will be retained in an identifiable state in a password protected database for potential unspecified research. If this data were to be used in the future, a new IRB would be submitted.
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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.
Catherine Hart, MD principal investigator
CCHMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Drug-eluting Stent Mometasone in people with Choanal Atresia, run by Children's Hospital Medical Center, Cincinnati 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 1 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: withdrawn, as of the sponsor's last update on 6 Apr 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Assessment of Posterior Nasal Cavity (time frame: 12 Months). 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 NCT03605537, which also lists 6 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 6 Apr 2021.