Xiangtong TM Full Degradation Sinus Drug Stent System Prospective, Open, Single-center, Randomized Controlled Clinical Trial

NCT06669130 | Not Yet Recruiting

• 1 other identifier: 2024-SR-350
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Xiangtong® Fully Degradable Sinus Drug Stent System is a high-tech medical device independently developed by Puyi Bio, specially designed for patients with chronic rhinosinusitis (CRS) undergoing endoscopic sinus surgery (ESS).The product is implanted into the target site during and after surgery, which not only supports the separation of the wound and fixes the repaired mucosal flap, but also controls edema, prevents adhesions, maintains smooth drainage, and sustains the target site to fight against inflammation and promotes healing by means of slow-release hormones.

Conditions

Chronic Rhinosinusitis (CRS)

Outcome Measures

Primary Outcomes (1)

• Postoperative reintervention rates based on imaging evaluations

  30 days after operation

Study Arms (2)

Xiangtong TM full degradation sinus drug stent system

EXPERIMENTAL

Device: Xiangtong TM full degradation sinus drug stent system

nasopore

PLACEBO COMPARATOR

Device: nasopore

Interventions

Xiangtong TM full degradation sinus drug stent system DEVICE

use Xiangtong TM full degradation sinus drug stent system to deliver drugs into sinus

Xiangtong TM full degradation sinus drug stent system

nasopore DEVICE

use nasopore to protect the post-operative sinus

nasopore

Eligibility Criteria

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

You may qualify if:

• Subjects are 18-65 years of age, male or non-pregnant female. The subject/legally authorized representative understands the purpose and procedures of the trial and voluntarily signs an informed consent form.
• Subjects must meet the diagnostic guidelines for chronic rhinosinusitis, have a confirmed diagnosis of bilateral chronic rhinosinusitis, and have a CT scan confirming bilateral Lund-Mackay scores \>6 (CT scan within 3 months prior to surgery is valid).
• Female subjects who are not breastfeeding at the time of the screening visit and who do not plan to breastfeed or become pregnant for up to one year after the starting point.
• Subject has not participated in another clinical trial in the previous 3 months and agrees not to participate in another clinical trial until the endpoints of this trial have been met.

You may not qualify if:

• Subject has a known allergic reaction or contraindication to the device material and its degradation products (mometasone acid, levulinic acid, racemic polylactic acid, propyl lactate, lactic acid).
• The subject is on long-term oral hormonal medications.
• The subject is receiving immunosuppressive therapy or has a known immunosuppressive or autoimmune disease: the subject has diabetes mellitus.
• The subject has or has had glaucoma or high intraocular pressure.
• The subject has cataracts.
• The subject has an artificial eye.
• Acute bacterial sinusitis and acute fungal sinusitis.
• Subject has a life expectancy of less than 12 months.
• Subject has participated in a clinical trial of another drug or device that did not meet the primary study endpoint: Subject is unable or unwilling to participate in this trial.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Central Study Contacts

Cheng Lei

CONTACT

13776620807; chenglei@jsph.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 1, 2024
• Study Start: December 1, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2027
• Last Updated: November 1, 2024

Record last verified: 2024-10