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Completed

NCT Number: NCT00791934

Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide

Study Design:

A non-randomized, multi-center, prospective, clinical study intended to evaluate the safety and efficacy of treating the ethmoid sinuses with the Ethmoid Sinus Spacer and Access System used for the local delivery of Triamcinolone Acetonide, over a period of 28 days.

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Key information

Conditions

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

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female subjects age 17 years or older
  • Radiographic evidence of ethmoid disease (baseline CT scan obtained within 30 days of scheduled surgery)
  • Diagnosis of chronic sinusitis and failed medical management (minimum of 3 weeks of antibiotics)

Exclusion criteria

  • Age < 17 years old
  • History of glaucoma or diagnosis of glaucoma (baseline visual exam indicating IOP >21 mmHg)
  • Adequate anatomical distances for treatment
  • Patient received oral steroid treatment within two weeks prior to day of surgery
  • Radiographic evidence of extensive sinonasal osteoneogenesis which could prevent device placement
  • Sinonasal tumors or obstructive lesions
  • History of facial trauma that distorts sinus anatomy and precludes access to the ethmoid sinus
  • Contracted/underdeveloped ethmoid sinus
  • Dehiscent lamina orbitalis
  • Previous ethmoid surgery
  • Ethmoid mucocele
  • Extensive Nasal Polyps
  • Asthmatic patients with aspirin sensitivity
  • Pregnant or lactating females

Treatment and study plan

Stratus Microflow Ethmoid Spacer

Device

The Spacer is inserted surgically into the ethmoid complex through the use of a sinus access system. Triamcinolone acetonide will be administered into the Spacer for this investigational study. The Spacer will be left in the ethmoid sinus for a period of 28 days. At the end of the implant period, the device is removed with standard instrumentation, during a follow-up office visit.

Other names: Ethmoid Spacer

Primary outcomes

  1. Mean Intrapatient Change in Ethmoid Lund-MacKay CT Score (Ethmoid Score Only) at 10 Weeks Post-procedure Compared to Baseline.

    Time frame: 10 weeks post-procedure

    The Lund-MacKay (LMK) CT (computed tomography) scoring system is used to evaluate radiographic opacification of the paranasal sinuses, an indicator of sinus disease. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. For this study endpoint, only the ethmoid sinus scores will be evaluated and totaled (left and right anterior and posterior ethmoid sinuses) where zero is the minimum score, and 8 is the maximum score. A higher score represents greater sinus disease burden. The LMK score will be evaluated at 10 weeks post-procedure compared to baseline.

Secondary outcomes

  1. Number of Participants With Decrease in Vision Greater Than 2 Lines Per Snellen Chart (BCVA at Baseline vs. BCVA 10 Week Post-procedure)

    Time frame: 10 weeks post surgery

    The Snellen eye chart will be used to evaluate participant's best-corrected visual acuity (BCVA, or best distance vision with eyeglasses or contact lenses) at baseline and at 10 week post-procedure. The number of participants with a decrease in vision greater than 2 lines per the Snellen eye chart are reported for this study endpoint.

  2. Number of Participants With Either a Change in Intraocular Pressure (IOP) ≥10mmHg OR Documented IOP > 21 mmHg

    Time frame: 10 weeks post-procedure

    Change in Intra-Ocular Pressure (IOP) of ≥ 10mmHg or documented IOP of > 21 mmHg were considered clinically significant (baseline compared to 10 weeks post-procedure).

  3. Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline

    Time frame: 1 year

    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, 10 weeks, and 1 year 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.

  4. Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline

    Time frame: 10 weeks

    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, 10 weeks, and 1 year 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.

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Collaborators

  • Acclarent

Registry information

Official study title

Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide (Kenalog-40)

Acronym: DELIVER

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Nov 17, 2008
Registry last updated
Aug 6, 2024

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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