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NCT00550914 Clinical Trial

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

Recurrent Respiratory Papillomatosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00550914
Other study ID # 07-01-005
Secondary ID 07-01-005
Status Completed
Phase N/A
First received October 26, 2007
Last updated July 6, 2010
Start date January 2007
Est. completion date June 2009

Study information
Verified date July 2010
Source Massachusetts Eye and Ear Infirmary
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 34
Est. completion date June 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 12 Years
Eligibility Inclusion Criteria:

1. Immunocompetent children ages 1-12 with symptomatic JORRP requiring operative intervention

2. Children who have historically required at least four surgeries in the year preceding enrollment to treat laryngeal JORRP

Exclusion Criteria:

1. Children who have required fewer than four procedures to treat laryngeal JORRP in the year prior to enrollment.

2. Children who are currently receiving adjuvant therapies for JORRP including cidofovir, interferon, indole-3-carbinol or Hsp-E7.

3. Caregivers who are non-English speaking as the PVRQOL instrument has been validated only in the English language.

4. Children whose families do not sign an informed consent to enter into the study.

5. Children whose families anticipate discontinuing care at a participating institution during the study period

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Massachusetts Eye and Ear Infirmary Boston Massachusetts
United States Rady Children's Hospital San Diego California

Sponsors (2)
Lead Sponsor Collaborator
Massachusetts Eye and Ear Infirmary Rady Children's Hospital, San Diego

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measure: Time interval between surgical therapy for recurrent respiratory papillomatosis One Year No
Secondary Measure: Validated voice questionnaire and intraoperative laryngoscopic staging score One Year No
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