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

NCT ID: NCT06669130

Last Updated: 2024-11-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2027-10-01

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Xiangtong TM full degradation sinus drug stent system

Group Type: EXPERIMENTAL

Xiangtong TM full degradation sinus drug stent system

Intervention Type: DEVICE

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

nasopore

Group Type: PLACEBO_COMPARATOR

nasopore

Intervention Type: DEVICE

use nasopore to protect the post-operative sinus

Interventions

Xiangtong TM full degradation sinus drug stent system

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

Intervention Type: DEVICE

nasopore

use nasopore to protect the post-operative sinus

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Cheng Lei

Role: CONTACT

chenglei@jsph.org.cn

13776620807

Other Identifiers

2024-SR-350

Identifier Type: -

Identifier Source: org_study_id