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

NCT06198894 | Recruiting DMC

• 1 other identifier: Stent-001
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Sinusitis

Keywords

steroid-eluting sinus stent; mucous edema

Outcome Measures

Primary Outcomes (1)

• Change in Sino-Nasal Outcome Test Scores (SNOT-22)

  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 Outcomes (5)

• Change in Sino-Nasal Outcome Test Scores (SNOT-22)

  Change from Baseline to Week 1, 2, 8, 12

• Change in nasal symptoms

  Change from Baseline to Week 1, 2, 4, 8, 12

• Rescue medication use

  Week 4 and Week 12

• The rate of surgery rate

  Week 4 and Week 12

• Lund-Kennedy Scoring for Nasal Endoscopy

  Change from Baseline to Week 1, 2, 4

Study Arms (2)

Steroid-eluting Sinus Implant

EXPERIMENTAL

In-office bilateral placement of the sinus stent; Systemic glucocorticoid placebo; saline irrigations (250ml) twice daily

Procedure: steroid-eluting sinus stent implant; Drug: saline irrigations; Drug: Placebo

Control

SHAM COMPARATOR

In-office bilateral sham procedure; Systemic glucocorticoid; saline irrigations (250ml) twice daily

Drug: Systemic glucocorticoids; Drug: saline irrigations; Procedure: sham procedure

Interventions

steroid-eluting sinus stent implant PROCEDURE

In-office bilateral placement of the steroid-eluting sinus stent in the ethmoid sinuses under local anesthesia

Also known as: BISORB bioabsorbable steroid-eluting sinus stent

Steroid-eluting Sinus Implant

Systemic glucocorticoids DRUG

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),

Also known as: Medrol

Control

saline irrigations DRUG

Patients were routinely treated with saline irrigations (250ml) twice daily

Also known as: 0.9% sodium chloride solution

Control; Steroid-eluting Sinus Implant

Placebo DRUG

Groups were given systemic glucocorticoid placebo

Also known as: Systemic glucocorticoid placebo

Steroid-eluting Sinus Implant

sham procedure PROCEDURE

The sham procedure was performed in-office under local anesthesia

Also known as: In-office bilateral sham procedure of stent placement

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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,

Sponsors & Collaborators

• Zheng Liu: lead

Study Sites (1)

Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (2)

• Forwith KD, Han JK, Stolovitzky JP, Yen DM, Chandra RK, Karanfilov B, Matheny KE, Stambaugh JW, Gawlicka AK. RESOLVE: bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis after sinus surgery: 6-month outcomes from a randomized, controlled, blinded study. Int Forum Allergy Rhinol. 2016 Jun;6(6):573-81. doi: 10.1002/alr.21741. Epub 2016 Mar 14.

  PMID: 26992115 BACKGROUND

• Van Zele T, Gevaert P, Holtappels G, Beule A, Wormald PJ, Mayr S, Hens G, Hellings P, Ebbens FA, Fokkens W, Van Cauwenberge P, Bachert C. Oral steroids and doxycycline: two different approaches to treat nasal polyps. J Allergy Clin Immunol. 2010 May;125(5):1069-1076.e4. doi: 10.1016/j.jaci.2010.02.020.

  PMID: 20451040 BACKGROUND

MeSH Terms

Interventions

Methylprednisolone; Sodium Chloride

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Zheng Liu

CONTACT

86 027 83663807; zhengliuent@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were blindfolded and earmuffed during the baseline procedure and follow-up endoscopic examinations. Implants were biodegradation at Week 4 to allow blinded assessment of bilateral edema score grade.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Otolaryngology-Head & Neck Surgery; Deputy Dean of Tongji Medical College; Deputy Dean of Tongji Hospital of Tongji Medical College

Model Details: Stent-001 is a randomized (1:1), sham-controlled, parallel group, single-blind, non-inferiority, multicenter study

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 10, 2024
• Study Start: January 10, 2024
• Primary Completion: January 10, 2026
• Study Completion: April 10, 2026
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

CN (1)