Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT02854761 - Safety Study of EF-022 in Adults With Recurrent Respiratory Papillomatosis (RRP) Phase 1
Terminated NCT00747461 - Interventional Cryotherapy for the Eradication of Benign Airway Disease ("ICE the BAD") Phase 4
Completed NCT01020747 - Bevacizumab for Treatment of Recurrent Respiratory Papillomatosis (RRP) Phase 1
Completed NCT00038714 - A Trial Study of SGN-00101 in Treating Pediatric Patients With Recurrent Respiratory Papillomatosis Phase 2
Completed NCT00205374 - Use of Cidofovir for Recurrent Respiratory Papillomatosis Phase 4
Active, not recruiting NCT04724980 - Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis Phase 1/Phase 2
Not yet recruiting NCT04645602 - Lenvatinib and Pembrolizumab Combination Therapy In HPV-associated Recurrent Respiratory Papilloma Patients With Laryngeal, Tracheal, and/or Pulmonary Involvement Phase 2
Recruiting NCT01793168 - Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Withdrawn NCT01058317 - Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis Phase 2/Phase 3
Withdrawn NCT00829608 - Therapeutic Treatment With Human Papillomavirus Quadrivalent Vaccine for Recurrent Respiratory Papillomatosis Phase 0
Not yet recruiting NCT01995721 - 4-valent HPV Vaccine to Treat Recurrent Respiratory Papillomatosis in Children Phase 3
Completed NCT02217358 - Value of Narrow Band Imaging (NBI) Endoscopy in the Early Diagnosis of Laryngeal Cancer and Precancerous Lesions N/A
Completed NCT00571701 - Study of Celebrex (Celecoxib) in Patients With Recurrent Respiratory Papillomatosis Phase 2
Recruiting NCT02555800 - Bevacizumab Versus Cidofovir for the Treatment of Recurrent Respiratory Papillomatosis Phase 2
Completed NCT03707587 - M7824 in People With Recurrent Respiratory Papillomatosis Phase 2
Completed NCT02859454 - Avelumab for People With Recurrent Respiratory Papillomatosis Phase 2
Active, not recruiting NCT02632344 - Pembrolizumab for HPV-associated Recurrent Respiratory Papilloma Patients Phase 2
Completed NCT02592902 - Recurrent Respiratory Papillomatosis and Extraesophageal Reflux N/A
Recruiting NCT06412172 - The Natural History and Biological Study of Pulmonary Recurrent Respiratory Papillomatosis (pRRP)
Recruiting NCT03465280 - Airway Intervention Registry (AIR): Recurrent Respiratory Papillomatosis (RRP)