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

Completed

Conditions studied: Recurrent Respiratory Papillomatosis

In brief

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.

Key facts

Study ID

NCT00550914

Run by

Massachusetts Eye and Ear Infirmary

People needed

34

Starts

2007-01-01

Expected to finish

2009-06-01

Last updated by the study team

2010-07-08

Who can join

Age: 1 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Rady Children's Hospital — San Diego, California, United States
• Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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