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

October 30, 2024 updated by: The First Affiliated Hospital with Nanjing Medical University

Efficacy and Safety of Xiangtong TM Full Degradation Sinus Drug Stent System

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

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

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:

  • 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.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Xiangtong TM full degradation sinus drug stent system
Device: Xiangtong TM full degradation sinus drug stent system
use Xiangtong TM full degradation sinus drug stent system to deliver drugs into sinus
Placebo Comparator: nasopore
Device: nasopore
use nasopore to protect the post-operative sinus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative reintervention rates based on imaging evaluations
Time Frame: 30 days after operation
30 days after operation

Collaborators and Investigators

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

Sponsor

The First Affiliated Hospital with Nanjing Medical University

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)

December 1, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

October 30, 2024

First Submitted That Met QC Criteria

October 30, 2024

First Posted (Estimated)

November 1, 2024

Study Record Updates

Last Update Posted (Estimated)

November 1, 2024

Last Update Submitted That Met QC Criteria

October 30, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-SR-350

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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