NCT07714525 Triamcinolone Nanocapsules After Endoscopic Nasal Surgery
| NCT ID | NCT07714525 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Deraya University |
| Condition | Chronic Rhinosinusitis (CRS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-05-01 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2026-05-01 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This randomised, single-masked, parallel-group clinical trial will evaluate the efficacy and safety of a topical triamcinolone acetonide-loaded polymeric nanocapsule formulation for postoperative care following endoscopic nasal surgery. Participants will receive either the investigational triamcinolone acetonide-loaded nanocapsule formulation or standard normal saline nasal irrigation. Postoperative nasal healing, inflammation, patient-reported sinonasal symptoms, postoperative complications, and corticosteroid-related adverse effects will be compared between the two groups.
Eligibility Criteria
Inclusion Criteria * Adults aged 18 to 60 years. * Patients scheduled to undergo one of the following procedures: * Functional endoscopic sinus surgery * Endoscopic turbinoplasty * Endoscopic septoplasty * Diagnosis of chronic rhinosinusitis and/or nasal polyps requiring surgical intervention. * Ability and willingness to provide written informed consent. * Ability and willingness to comply with study treatment and scheduled follow-up visits. Exclusion Criteria * Known hypersensitivity to triamcinolone acetonide. * Known hypersensitivity to any component of the polymeric nanocapsule formulation. * Systemic contraindication to corticosteroid therapy. * Active severe nasal or sinonasal infection at the time of enrollment or treatment. * Pregnancy or breastfeeding, if excluded in the approved protocol. * Uncontrolled diabetes mellitus, if corticosteroid exposure is considered clinically relevant. * Immunosuppression or use of immunosuppressive therapy. * Recent use of systemic or intranasal corticosteroids within the protocol-defined washout period. * Participation in another clinical trial. * Any medical or psychiatric condition that may interfere with informed consent, study treatment, or follow-up. * Inability to complete the required questionnaires or follow-up visits.
Contact & Investigator
Sally Mansour Helmy
PRINCIPAL INVESTIGATOR
Deraya University
Frequently Asked Questions
Who can join the NCT07714525 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Chronic Rhinosinusitis (CRS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07714525 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07714525 currently recruiting?
Yes, NCT07714525 is actively recruiting participants. Contact the research team at aliaa.gamal@deraya.edu.eg for enrollment information.
Where is the NCT07714525 trial being conducted?
This trial is being conducted at Minya, Egypt.
Who is sponsoring the NCT07714525 clinical trial?
NCT07714525 is sponsored by Deraya University. The principal investigator is Sally Mansour Helmy at Deraya University. The trial plans to enroll 50 participants.