Skip to content

Evaluation of the efficacy of olfactory fissure implantation of bioabsorbable sinus steroid eluting stent for the treatment of olfactory dysfunction associated with chronic sinusitis

Evaluation of the efficacy of olfactory fissure implantation of bioabsorbable sinus steroid eluting stent for the treatment of olfactory dysfunction associated with chronic sinusitis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064372
Enrollment
Unknown
Registered
2022-10-05
Start date
2022-11-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

olfactory dysfunction associated with chronic sinusitis

Interventions

Test group (stent implantation side):implanting bioabsorbable sinus steroid eluting stent into olfactory cleft
control group(Opposite to the stent placement side):no stent

Sponsors

the Second People's Hospital of Shenzhen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
21 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. All patients with sinusitis were clinically diagnosed in accordance with the European opinion on the diagnosis and treatment of sinusitis and nasal polyps 2020 crswnp diagnostic guidelines, and were intended for initial surgical treatment; 2. The diagnosis of olfactory dysfunction in all patients should comply with the European opinion on the diagnosis and treatment of sinusitis and nasal polyps 2020 diagnostic guidelines for chronic sinusitis-related olfactory dysfunction; 3. All patients received t&t standard olfactory test at admission, with scores of 3 or more and equal, that is, all patients had olfactory disorders to varying degrees; Polyps were found in bilateral olfactory cleft by endoscopic examination before operation; 4. 55 years old >= age >= 21 years old; 5. Volunteer to participate in this study and sign the informed consent for the placement of drug stents in nasal sinuses in olfactory fissure; 6. The subjects had a poor effect after pre-standardized drug treatment (> 3 months), and had a clear intention of surgery.

Exclusion criteria

Exclusion criteria: 1. The subjects had known allergic reactions or contraindications to the fully degradable nasal sinus drug stent and its degradation products (mometasone furoate, L-polylactic acid, racemic polylactic acid, lactide, lactic acid); 2. Need long-term oral hormone drugs; Patients who are receiving immunosuppressive therapy or are known to have immunosuppressive or autoimmune diseases; 3. Patients with severe diabetes or other serious diseases that affect the operation; 4. Suffering from acute inflammation and tumor of the nasal cavity and paranasal sinus; Patients with intracranial tumors; 5. There are contraindications related to endoscopic surgery; 6. Those who are mentally retarded and cannot cooperate to complete various scores.

Design outcomes

Primary

MeasureTime frame
Nasal olfactory t&t test score;

Secondary

MeasureTime frame
Modified nasal sinus CT olfactory fissure score;Olfactory fissure score of Lund Kennedy nasal endoscopy;

Countries

China

Contacts

Public ContactQingguo Meng
1932204089@qq.com+86 13923722676

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026