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OpenTrials
Completed

NCT Number: NCT01525849

Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up

The objective of this study is to show that long-term symptom improvement after sinus balloon dilation is not worse than symptom improvement after functional endoscopic sinus surgery (FESS) and that fewer postoperative debridements are required after balloon dilation than after FESS.

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Key information

Conditions

Chronic Sinusitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Entellus Medical

Plymouth, Minnesota, 55447, United States

About this study

This is a postmarket, multicenter, prospective, randomized clinical trial conducted at up to 15 US clinical sites comparing the efficacy of balloon sinus dilation with traditional endoscopic sinus surgery. The primary hypotheses were to demonstrate that: 1) long-term change in sinus symptoms after balloon dilation is not worse (non-inferior) than after FESS, and 2) balloon dilation is superior to FESS for a reduction in the number of postoperative debridements per patient. A minimum of 36 participants per arm is required to test the primary hypotheses. All participants will be followed through a minimum of 12 months post treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years or older
  • maxillary sinus disease
  • chronic sinusitis

Exclusion criteria

  • fungal disease
  • Samter's triad
  • hemophilia
  • prior sinus surgery

Treatment and study plan

Balloon Sinus Dilation

Device

Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool or the FinESS SInus Treatment

Functional Endoscopic Sinus Surgery

Procedure

Endoscopic sinus surgery, specifically, maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy

Primary outcomes

  1. Sinus Symptom Improvement

    Time frame: Baseline and 1-year

    Change from baseline in overall 20-item Sino-Nasal Outcome Test (SNOT-20) score. The SNOT-20 is a validated patient reported survey of 20 items related to sinonasal symptoms and severity assessed over the previous 2 weeks. Each item is scored from 0 (no problem) to 5 (problem as bad as it can be). The individual item scores are averaged to provide and overall score that ranges from 0 (best) to 5 (worst).

  2. Debridements

    Time frame: 1-year

    Number of postoperative debridements per participant

Secondary outcomes

  1. Revision Rate

    Time frame: 1-year

    Number of participants requiring repeat sinus procedures

  2. Complication Rate

    Time frame: Duration of study (minimum of 12 months)

    Number of participants experiencing 1 or more serious adverse events related to the device and/or procedure

  3. Recovery Time

    Time frame: 6-months

    Mean time (days) after procedure for participants to return to normal activities

Sponsors and collaborators

Lead sponsor

Entellus Medical, Inc.

Industry

Registry information

Acronym: REMODEL

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 3, 2012
Registry last updated
Feb 24, 2017

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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