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 range

1 Year – 12 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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