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Completed

NCT Number: NCT01115309

XprESS Registry Study

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).

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Key information

Conditions

Sinusitis Infections Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Sinus Center

San Antonio, Texas, 78006, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XprESS Balloon Device

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).

Primary outcomes

  1. Safety Assessments

    Time frame: 1 month after procedure

    Adverse event reporting as related to XprESS device or procedure

Secondary outcomes

  1. Sino-Nasal Outcome Test (SNOT-20) at 1 Month

    Time frame: Baseline and 1 month after procedure

    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.

  2. SNOT-20 at 6 Months

    Time frame: Baseline and 6 months post procedure

    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.

  3. SNOT-20 at 12 Months

    Time frame: Baseline and 12 months post procedure

    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.

Other outcomes

  1. Number of Sinuses Demonstrating Functional Patency

    Time frame: 12 months post procedure

    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.

Sponsors and collaborators

Lead sponsor

Entellus Medical, Inc.

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 4, 2010
Registry last updated
Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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