NCT07499791 Absorbable Drug-Eluting Lacrimal Sac Stent for Recurrent Chronic Dacryocystitis
| NCT ID | NCT07499791 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Beijing Tongren Hospital |
| Condition | Chronic Dacryocystitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-05-01 |
| Primary Completion | 2027-12-01 |
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 40 participants in total. It began in 2026-05-01 with a primary completion date of 2027-12-01.
⚠ 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 study aims to evaluate the safety and effectiveness of an absorbable lacrimal sac drug-eluting stent placed at the osteotomy site during endoscopic endonasal dacryocystorhinostomy (E-DCR) in patients with recurrent chronic dacryocystitis. The stent is composed of absorbable polymer mesh coated with mometasone furoate to reduce postoperative inflammation and adhesion, maintain ostium patency, and improve surgical outcomes. A total of 40 patients will be randomized 1:1 to receive either the absorbable stent or conventional packing with routine postoperative intranasal budesonide therapy.
Eligibility Criteria
Inclusion Criteria: * Diagnosed chronic dacryocystitis History of failed E-DCR or lacrimal intubation Preoperative dacryocystography showing lacrimal sac diameter ≥4 mm Age ≥18 years Able to consent and comply with procedures Exclusion Criteria: * Nasal cavity structural disease: severe septal deviation, tumor, severe sinusitis Lacrimal sac non-visualization on imaging Lacrimal sac rupture, traumatic duct/bone injuries Allergy to mometasone furoate or PLA/PGA polymers Poor general health, unable to tolerate surgery Psychiatric disorders or antipsychotic drug use Uncontrolled hypertension, diabetes, or severe systemic diseases Keloid tendency Coagulation disorders Pregnancy
Contact & Investigator
Chengshuo Wang
STUDY CHAIR
Beijing Tongren Hospital
Frequently Asked Questions
Who can join the NCT07499791 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Chronic Dacryocystitis. 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 NCT07499791 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 NCT07499791 currently recruiting?
Yes, NCT07499791 is actively recruiting participants. Contact the research team at wangcs830@126.com for enrollment information.
Where is the NCT07499791 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China.
Who is sponsoring the NCT07499791 clinical trial?
NCT07499791 is sponsored by Beijing Tongren Hospital. The principal investigator is Chengshuo Wang at Beijing Tongren Hospital. The trial plans to enroll 40 participants.