CompletedNot Applicable

Multi-Center, Randomized Trial of the Pulsed Dye Laser for JORRP

United States34 participantsStarted 2007-01

Plain-language 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.

Who can participate

Age range1 Year – 12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Measure: Time interval between surgical therapy for recurrent respiratory papillomatosis

Timeframe: One Year

Trial details

NCT IDNCT00550914

SponsorMassachusetts Eye and Ear Infirmary

Sponsor typeOTHER

Study typeOBSERVATIONAL

View on ClinicalTrials.gov More Recurrent Respiratory Papillomatosis trials