Last updated: January 17, 2024
Sponsor: Zheng Liu
Overall Status: Active - Recruiting
Phase
N/A
Condition
Rhinitis, Allergic, Perennial
Sinus Infections
Sinusitis
Treatment
Placebo
Systemic glucocorticoids
sham procedure
Clinical Study ID
NCT06198894
Stent-001
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- The patient underwent pre-functional endoscopic sinus surgery and bilateralethmoidectomy (for at least 3 months), and was identified by the clinician as havinguncontrolled symptoms (Diagnostic criteria of EPOS 2020) with a Snot-22 score of atleast 20;
- Edema score of bilateral nasal endoscopy was 2 points both;
- Understands the purpose and procedures of the trial and voluntarily signs the informedconsent form;
- The female subjects had no pregnancy or lactation plans during the treatment andfollow-up period;
- The subject has not participated in other clinical trials in the previous three monthsand agrees not to participate in other clinical trials until the end point of thistrial was reached;
- Subjects were 18-65 years old, male or non-pregnant women;
Exclusion
Exclusion Criteria:
- Grade 2 or more nasal polyp scores in either nasal cavity (i.e., polyps extendingbeyond the middle nasal passage)
- The subject has a known allergic reaction or contraindication to the device materialand its degradation products (mamethasone citrate, L-polylactic acid, racemicpolylactic acid, lactide lactate, lactic acid);
- Subjects had cystic fibrosis, congenital ciliary dyskinesia, fungal globularsinusitis, systemic vasculitis and granulomatous diseases, tumors, and immunedeficiency.
- The patient underwent endoscopic nasal surgery within 3 months.
- Acute exacerbation of allergic rhinitis, acute exacerbation of CRS, upper respiratorytract infection, or common cold in the 4 weeks prior to screening visit;
- Have a clinically serious metabolic, cardiovascular, immune, neurological, blood,digestive, cerebrovascular, or respiratory disease, or any condition that theinvestigator believes interferes with the evaluation of the study results or affectsthe safety of the subjects;
- Symptomatic seasonal allergic rhinitis, and/or, depending on the season, expected todevelop symptoms and require nasal spray hormone therapy within 4 weeks ofrandomization,
Study Design
Total Participants: 96
Treatment Group(s): 5
Primary Treatment: Placebo
Phase:
Study Start date:
January 10, 2024
Estimated Completion Date:
April 10, 2026
Study Description
Connect with a study center
Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei 430030
ChinaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.