Steroid-eluting Sinus Stent for Chronic Rhinosinusitis Patients With Uncontrolled Postoperative Symptoms

January 17, 2024 updated by: Zheng Liu

Study on the Efficacy of in Office Steroid-eluting Sinus Stent Implantation in Chronic Rhinosinusitis Patients With Uncontrolled Postoperative Symptoms

Stent-001 study is a randomized controlled clinical trial with the steroid-eluting Sinus in 96 chronic rhinosinusitis patients with uncontrolled postoperative symptoms

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Stent-001 is a randomized (1:1), sham-controlled, parallel group, single-blind, non-inferiority, multicenter study in 96 chronic rhinosinusitis patients who had prior endoscopic sinus surgery and presented with uncontrolled postoperative symptoms. The objective was to evaluate the safety and clinical efficacy of sinus stents relative to systemic glucocorticoids. The steroid-eluting sinus stent consist of a bioabsorbable self-expanding sinus implant coated with 625 mcg of mometasone furoate (MF) and a single-use delivery system. Implant is placed in-office in the ethmoid sinus under local anesthesia. The coating on the sinus stent implant provides controlled release of MF to the sinus mucosa over 30 days.

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
        • Principal Investigator:
          • Zheng Liu, doctor
        • Principal Investigator:
          • Heng Wang, doctor
        • Contact:
          • Wang, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The patient underwent pre-functional endoscopic sinus surgery and bilateral ethmoidectomy (for at least 3 months), and was identified by the clinician as having uncontrolled symptoms (Diagnostic criteria of EPOS 2020) with a Snot-22 score of at least 20;
  • Edema score of bilateral nasal endoscopy was 2 points both;
  • Understands the purpose and procedures of the trial and voluntarily signs the informed consent form;
  • The female subjects had no pregnancy or lactation plans during the treatment and follow-up period;
  • The subject has not participated in other clinical trials in the previous three months and agrees not to participate in other clinical trials until the end point of this trial was reached;
  • Subjects were 18-65 years old, male or non-pregnant women;

Exclusion Criteria:

  • Grade 2 or more nasal polyp scores in either nasal cavity (i.e., polyps extending beyond the middle nasal passage)
  • The subject has a known allergic reaction or contraindication to the device material and its degradation products (mamethasone citrate, L-polylactic acid, racemic polylactic acid, lactide lactate, lactic acid);
  • Subjects had cystic fibrosis, congenital ciliary dyskinesia, fungal globular sinusitis, systemic vasculitis and granulomatous diseases, tumors, and immune deficiency.
  • The patient underwent endoscopic nasal surgery within 3 months.
  • Acute exacerbation of allergic rhinitis, acute exacerbation of CRS, upper respiratory tract 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 the investigator believes interferes with the evaluation of the study results or affects the safety of the subjects;
  • Symptomatic seasonal allergic rhinitis, and/or, depending on the season, expected to develop symptoms and require nasal spray hormone therapy within 4 weeks of randomization,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Steroid-eluting Sinus Implant
In-office bilateral placement of the sinus stent; Systemic glucocorticoid placebo; saline irrigations (250ml) twice daily
Procedure: steroid-eluting sinus stent implant
In-office bilateral placement of the steroid-eluting sinus stent in the ethmoid sinuses under local anesthesia
Other Names:
  • BISORB bioabsorbable steroid-eluting sinus stent
Drug: saline irrigations
Patients were routinely treated with saline irrigations (250ml) twice daily
Other Names:
  • 0.9% sodium chloride solution
Drug: Placebo
Groups were given systemic glucocorticoid placebo
Other Names:
  • Systemic glucocorticoid placebo
Sham Comparator: Control
In-office bilateral sham procedure; Systemic glucocorticoid; saline irrigations (250ml) twice daily
Drug: saline irrigations
Patients were routinely treated with saline irrigations (250ml) twice daily
Other Names:
  • 0.9% sodium chloride solution
Drug: Systemic glucocorticoids
Groups were given oral methylprednisolone (32 mg/d on days 1-5; 16 mg/d on days 6-10; and 8 mg/d on days 11-20),
Other Names:
  • Medrol
Procedure: sham procedure
The sham procedure was performed in-office under local anesthesia
Other Names:
  • In-office bilateral sham procedure of stent placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sino-Nasal Outcome Test Scores (SNOT-22)
Time Frame: Change from Baseline to Week 4
The change in Sino-Nasal Outcome Test scores (SNOT-22) scores pre- and post-treatment between the two arms was measured. The Sino-Nasal Outcome Test asks subjects to rate how "bad" their rhinosinusitis is by using a 0-5 point scale with 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be. The SNOT includes 22 questions (symptoms and social/emotional consequences of rhinosinusitis), each of which are rated from 0 to 5 for a minimum score of 0 to maximum score of 110, with higher scores representing worse outcome.
Change from Baseline to Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sino-Nasal Outcome Test Scores (SNOT-22)
Time Frame: Change from Baseline to Week 1, 2, 8, 12
The change in Sino-Nasal Outcome Test scores (SNOT-22) scores pre- and post-treatment between the two arms was measured. The Sino-Nasal Outcome Test asks subjects to rate how "bad" their rhinosinusitis is by using a 0-5 point scale with 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be. The SNOT includes 22 questions (symptoms and social/emotional consequences of rhinosinusitis), each of which are rated from 0 to 5 for a minimum score of 0 to maximum score of 110, with higher scores representing worse outcome.
Change from Baseline to Week 1, 2, 8, 12
Change in nasal symptoms
Time Frame: Change from Baseline to Week 1, 2, 4, 8, 12
Nasal symptoms measured by Visual analog score. The four nasal symptoms (nasal obstruction, rhinorrhea, headache and olfactory disorder) involved in assigning the total nasal symptom score(TNSS). The symptoms are graded on a10-point scale (0 = no symptoms;10 = most severe symptoms).
Change from Baseline to Week 1, 2, 4, 8, 12
Rescue medication use
Time Frame: Week 4 and Week 12
If polyps and/or the moderate to severe clinical symptoms of CRS were relapsed and/or not controlled throughout the study period, rescue medication of corticosteroids for the experimental group will be used and recorded.
Week 4 and Week 12
The rate of surgery rate
Time Frame: Week 4 and Week 12
The rate of nasal endoscopic surgery for the experimental or control group throughout the study period will be recorded.
Week 4 and Week 12
Lund-Kennedy Scoring for Nasal Endoscopy
Time Frame: Change from Baseline to Week 1, 2, 4
The Lund Kennedy scoring system for nasal endoscopy rates the severity of the sinusitis based on the endoscopic appearance of the nasal mucosa. Edema, secretions, and the presence of polyps are rated from 0-2, for a total maximum score of 6 per each side of the nose. Higher scores represent more severe disease.
Change from Baseline to Week 1, 2, 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zheng Liu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 10, 2024

Primary Completion (Estimated)

January 10, 2026

Study Completion (Estimated)

April 10, 2026

Study Registration Dates

First Submitted

December 27, 2023

First Submitted That Met QC Criteria

December 27, 2023

First Posted (Actual)

January 10, 2024

Study Record Updates

Last Update Posted (Actual)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Stent-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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