Clinical trial · Observational
Multi-Center, Randomized Trial of the Pulsed Dye Laser for JORRP
A Multi-Center, Randomized, Controlled Trial of the Pulsed Dye Laser for Juvenile Onset Recurrent Respiratory Papillomatosis
NCT00550914CI-TRIAL-00003653completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Respiratory Papillomatosis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Control arm
- description
- The conventional therapy arm will undergo debridement with either a powered microdebrider or cold instrumentation excision as per the preference of the individual surgeon. Debridement will be deemed complete after removal of gross papilloma to the extent that the individual surgeon feels can be safely accomplished. Standard microsurgical principles of the larynx will guide debridement in that no opposing mucosal surfaces of the true vocal folds, laryngeal ventricle or inter-arytenoid space will be simultaneously debrided
- label
- Experimental Arm
- description
- Patients enrolled into the conventional therapy plus PDL treatment arm will undergo debridement of the supraglottis and subglottis via conventional techniques as per the individual surgeons preferences followed by therapy to anterior commissure, true vocal folds, laryngeal ventricle and inter-arytenoid space with the pulsed dye laser. Standard laser settings will be a 450 microsecond pulse width, 5 J per pulse maximum of 1Hz, 1 mm spot fiber, 1-2 mm spot size and fluences of 38-255 J/cm2.
Primary outcomes (1)
- measure
- Measure: Time interval between surgical therapy for recurrent respiratory papillomatosis
- timeFrame
- One Year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 12 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.