Balloon Sinus Dilation In Office or OR

NCT00939393 | Completed Results FDA Device

• 1 other identifier: CPR005002
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopic sinus surgery will be performed either in the physician's office or in the operating room (OR). Patients treated in the physician's office will have endoscopic sinus surgery performed with balloon sinuplasty devices. Patients treated in the OR will have endoscopic sinus surgery performed with or without balloon sinuplasty devices.

Conditions

Chronic Sinusitis

Outcome Measures

Primary Outcomes (1)

• Mean Intra-patient Change in SNOT-20 Score at 24 Weeks Post-procedure Compared to Baseline

  The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.

  24 weeks

Secondary Outcomes (9)

• Mean Intra-patient Change in Lund-MacKay CT Score [24 Weeks]

  24 weeks

• Proportion of Participants Rating Procedure as Tolerable (IO Only)

  Day 0

• Proportion of Participants Reporting No Pain or Pain of Low Intensity (IO Only)

  Day 0

• Mean Number of Debridements Per Participant (IO Only)

  52 weeks

• Proportion of Participants With Revisions (IO Only)

  52 weeks

Study Arms (2)

FESS in OR with or without balloons

ACTIVE COMPARATOR

Functional Endoscopy Sinus Surgery

Device: FESS instruments with or without balloon treatment

Balloon sinuplasty in physician office

ACTIVE COMPARATOR

Balloon Sinuplasty in physician office using Acclarent devices

Device: Balloon Sinuplasty

Interventions

Balloon Sinuplasty DEVICE

Balloon dilatation of sinuses

Balloon sinuplasty in physician office

FESS instruments with or without balloon treatment DEVICE

Intervention with metal instruments with or without balloon treatment

FESS in OR with or without balloons

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years and greater
• Both male and female patients eligible
• Diagnosis of chronic sinusitis that is not responsive to medical management (\> 12 weeks of symptoms and failed at least 3 to 6 weeks of appropriate antibiotic therapy as evidenced by presence of disease on CT scan)
• Planned endoscopic sinus surgery (recommended by investigator, consented to by patient)

You may not qualify if:

• Cystic fibrosis
• Samter's Triad (Aspirin sensitivity, Asthma, Sinonasal polyposis)
• Sinonasal tumors or obstructive lesions
• History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium
• Ciliary dysfunction
• Pregnant females

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead
• Acclarent: collaborator

Study Sites (1)

Rockside Road Surgery Center

Independence, Ohio, 44131, United States

Location

Results Point of Contact

• Title: Clinical Director
• Organization: Acclarent, Inc.

lenglan1@its.jnj.com

650-687-5888

Study Officials

• Howard Levine, MD

  Rockside Road Surgery Center Independence, OH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2009
• First Posted: July 15, 2009
• Study Start: April 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2010
• Last Updated: July 12, 2024
• Results First Posted: October 3, 2014

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)