Multi-Center, Randomized Trial of the Pulsed Dye Laser for JORRP
Completed
- Conditions
- Recurrent Respiratory Papillomatosis
- Registration Number
- NCT00550914
- Lead Sponsor
- Massachusetts Eye and Ear Infirmary
- Brief Summary
The purpose of this study is to determine whether the 585-nm pulse dye laser can decrease the time interval between surgeries and improve voice outcomes in children with severe RRP.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
- Immunocompetent children ages 1-12 with symptomatic JORRP requiring operative intervention
- Children who have historically required at least four surgeries in the year preceding enrollment to treat laryngeal JORRP
Exclusion Criteria
- Children who have required fewer than four procedures to treat laryngeal JORRP in the year prior to enrollment.
- Children who are currently receiving adjuvant therapies for JORRP including cidofovir, interferon, indole-3-carbinol or Hsp-E7.
- Caregivers who are non-English speaking as the PVRQOL instrument has been validated only in the English language.
- Children whose families do not sign an informed consent to enter into the study.
- Children whose families anticipate discontinuing care at a participating institution during the study period
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Measure: Time interval between surgical therapy for recurrent respiratory papillomatosis One Year
- Secondary Outcome Measures
Name Time Method Measure: Validated voice questionnaire and intraoperative laryngoscopic staging score One Year
Trial Locations
- Locations (2)
Rady Children's Hospital
🇺🇸San Diego, California, United States
Massachusetts Eye and Ear Infirmary
🇺🇸Boston, Massachusetts, United States