Recurrent Respiratory PapillomatosisNCT00550914
Multi-Center, Randomized Trial of the Pulsed Dye Laser for JORRP
An observational study of Recurrent Respiratory Papillomatosis, run by Massachusetts Eye and Ear Infirmary at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Recurrent Respiratory Papillomatosis
- How many people
- 34 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2007to Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with severe JORRP
Who may be able to join
- Immunocompetent children ages 1-12 with symptomatic JORRP requiring operative intervention
- Children who have historically required at least four surgeries in the year preceding enrollment to treat laryngeal JORRP
Who cannot join
- Children who have required fewer than four procedures to treat laryngeal JORRP in the year prior to enrollment.
- Children who are currently receiving adjuvant therapies for JORRP including cidofovir, interferon, indole-3-carbinol or Hsp-E7.
- Caregivers who are non-English speaking as the PVRQOL instrument has been validated only in the English language.
- Children whose families do not sign an informed consent to enter into the study.
- Children whose families anticipate discontinuing care at a participating institution during the study period
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
Rady Children's Hospital
San Diego, California
About this study
Official title: A Multi-Center, Randomized, Controlled Trial of the Pulsed Dye Laser for Juvenile Onset Recurrent Respiratory Papillomatosis
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
- Recurrent Respiratory Papillomatosis
- Keywords
- Papilloma, Papillomatosis, Laser, Laser Surgery
- Medical subject headings
- Recurrent respiratory papillomatosis, Papilloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | 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 | |
| Experimental Arm | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: Time interval between surgical therapy for recurrent respiratory papillomatosis
Measured: One Year
Secondary outcomes (1)
Measure: Validated voice questionnaire and intraoperative laryngoscopic staging score
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2007 (estimated)
- Study startJan 2007
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Respiratory PapillomatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Collaborators
- Rady Children's Hospital, San Diego
- Investigators
- Christopher Hartnick, M.D., Study chair, Massachusetts Eye and Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550914
- Sponsor's protocol ID
- 07-01-005
- Other IDs
- 07-01-005
- Status last verified
- Jul 2010
- First submitted
- 26 Oct 2007
- Last updated
- 8 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Controlled Trial of the Pulsed Dye Laser for Juvenile Onset Recurrent Respiratory Papillomatosis
- ClinicalTrials.gov ID
- NCT00550914
- Acronym / sponsor ID
- 07-01-005
- Conditions
- Recurrent Respiratory Papillomatosis
- Keywords
- Papilloma, Papillomatosis, Laser, Laser Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Collaborators
- Rady Children's Hospital, San Diego
- Study start
- Jan 2007
- Study completion
- Jun 2009 (actual)
- First posted
- 30 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | – | –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 |
| Experimental Arm | – | –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. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with severe JORRP
Key inclusion criteria (2 listed)
- Immunocompetent children ages 1-12 with symptomatic JORRP requiring operative intervention
- Children who have historically required at least four surgeries in the year preceding enrollment to treat laryngeal JORRP
Key exclusion criteria (5 listed)
- Children who have required fewer than four procedures to treat laryngeal JORRP in the year prior to enrollment.
- Children who are currently receiving adjuvant therapies for JORRP including cidofovir, interferon, indole-3-carbinol or Hsp-E7.
- Caregivers who are non-English speaking as the PVRQOL instrument has been validated only in the English language.
- Children whose families do not sign an informed consent to enter into the study.
- Children whose families anticipate discontinuing care at a participating institution during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure: Time interval between surgical therapy for recurrent respiratory papillomatosis
Time frame: One Year
1 secondary outcome
Measure: Validated voice questionnaire and intraoperative laryngoscopic staging score
Time frame: One Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Hartnick, M.D. study chair
Massachusetts Eye and Ear Infirmary
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Respiratory Papillomatosis, run by Massachusetts Eye and Ear Infirmary at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure: Time interval between surgical therapy for recurrent respiratory papillomatosis (time frame: One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2010.