XprESS Registry Study

Sinusitis Clinical Trial

Official title:

XprESS Registry Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01115309
• Other study ID #: 1677-001
• Status: Completed
• Phase: N/A
• Start date: April 2010
• Est. completion date: December 2011

Study information

• Verified date: October 2020
• Source: Entellus Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, non-randomized, multi-center study to assess safety and long-term patency of the ostia treated with the XprESS device per the device indication for use (IFU).

Description:

Endoscopic balloon-only and hybrid-balloon procedures involving dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia were performed in 175 patients.

One-month follow-up was required for all patients. The first 50 patients enrolled also consented to a 1-year follow-up. Complications and sinus symptom severity were assessed at the 1-month visit. Symptom severity and ostial patency of the treated sinuses were evaluated at the 1-year visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Scheduled to undergo sinus surgery with planned use of the XprESS Balloon Device consistent with the tool's Indication for Use

• Willing and able to provide consent

Exclusion Criteria:

• Known Samter's Triad

• History of primary ciliary dysfunction

• History of cystic fibrosis

• Known to be immunosuppressed

• Hemophilia

• Currently enrolled in another pre-approval investigational study

Related Conditions & MeSH terms

• Sinusitis

Intervention

Device:
• XprESS Balloon Device
Sinus dilation completed with the XprESS Balloon Device with or without additional endoscopic sinus surgery procedures (dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia).

Locations

Country	Name	City	State
United States	Texas Sinus Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Entellus Medical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Brodner D, Nachlas N, Mock P, Truitt T, Armstrong M, Pasha R, Jung C, Atkins J. Safety and outcomes following hybrid balloon and balloon-only procedures using a multifunction, multisinus balloon dilation tool. Int Forum Allergy Rhinol. 2013 Aug;3(8):652-8 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Sinuses Demonstrating Functional Patency	Functional patency of the sinus ostia originally treated with XprESS was assessed by the clinical site either by visual endoscopic evidence of a clear drainage path or radiographic evidence of a completely aerated sinus at 12-month follow-up for the first 50 patients treated in the study.	12 months post procedure
Primary	Safety Assessments	Adverse event reporting as related to XprESS device or procedure	1 month after procedure
Secondary	Sino-Nasal Outcome Test (SNOT-20) at 1 Month	The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20.	Baseline and 1 month after procedure
Secondary	SNOT-20 at 6 Months	The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20.	Baseline and 6 months post procedure
Secondary	SNOT-20 at 12 Months	The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20.	Baseline and 12 months post procedure