An observational study in Recurrent Respiratory Papillomatosis, sponsored by Massachusetts Eye and Ear Infirmary. Completed at 2 sites in United States. Open to participants aged 1 Year to 12 Years. Per ClinicalTrials.gov, last updated 2010-07-08.
Sponsored by Massachusetts Eye and Ear Infirmary · Observational
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.
1,031 studies on the registry are indexed under Respiratory Tract Infections; 144 are open to participants now.
This study's planned enrollment of 34 is below the median of 300 across 295 observational studies indexed under Respiratory Tract Infections.
Browse Respiratory Tract Infections studies →Massachusetts Eye and Ear Infirmary is the lead sponsor of 99 studies on the registry; 23 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 6 (46%) have results posted.
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Children with severe JORRP
Exclusion Criteria:
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
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.
Measure: Time interval between surgical therapy for recurrent respiratory papillomatosis
Time frame: One Year
Measure: Validated voice questionnaire and intraoperative laryngoscopic staging score
Time frame: One Year
This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
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Massachusetts Eye and Ear Infirmary