Skip to main content
OpenTrials
Completed

NCT Number: NCT00550914

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Recurrent Respiratory Papillomatosis Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Papilloma

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rady Children's Hospital, San Diego, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Measure: Time interval between surgical therapy for recurrent respiratory papillomatosis

    Time frame: One Year

Secondary outcomes

  1. Measure: Validated voice questionnaire and intraoperative laryngoscopic staging score

    Time frame: One Year

Sponsors and collaborators

Lead sponsor

Massachusetts Eye and Ear Infirmary

Other

Collaborators

  • Rady Children's Hospital, San Diego

Registry information

Official study title

A Multi-Center, Randomized, Controlled Trial of the Pulsed Dye Laser for Juvenile Onset Recurrent Respiratory Papillomatosis

Important dates

Study start
2007
Study completion
2009
First posted
Oct 30, 2007
Registry last updated
Jul 8, 2010

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.