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


N/A
1 Year
12 Years
Not Enrolling
Both
Recurrent Respiratory Papillomatosis

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Trial Information

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


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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Measure: Time interval between surgical therapy for recurrent respiratory papillomatosis

Outcome Time Frame:

One Year

Safety Issue:

No

Principal Investigator

Christopher Hartnick, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Massachusetts Eye and Ear Infirmary

Authority:

United States: Institutional Review Board

Study ID:

07-01-005

NCT ID:

NCT00550914

Start Date:

January 2007

Completion Date:

June 2009

Related Keywords:

  • Recurrent Respiratory Papillomatosis
  • Papilloma, Papillomatosis, Laser, Laser Surgery
  • Papilloma
  • Respiratory Tract Infections
  • Papillomavirus Infections

Name

Location

Massachusetts Eye and Ear InfirmaryBoston, Massachusetts  02114-3096
Rady Children's HospitalSan Diego, California  92123