Adenotonsillar HypertrophyPhase 2/3NCT00459927
Comparison of Floseal Hemostasis Tonsillectomy With Coblation Tonsillectomy and Cautery Hemostasis Tonsillectomy
A Phase 2/3 study testing Floseal tonsillectomy and Coblation tonsillectomy in people with Adenotonsillar Hypertrophy and Tonsillitis, run by Kaiser Permanente.
Trial summary
The purpose of this study is to evaluate a new method of hemostasis, floseal gel, in tonsillectomy and adenoidectomy, with the goal of decreasing post operative and intraoperative morbidity. Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Adenotonsillar Hypertrophy, Tonsillitis, Obstructive Sleep Apnea
- What is being tested?
- Floseal tonsillectomy and Coblation tonsillectomy
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to not given
- Phase
- Phase 2/3
- 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 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients less than 18 years old scheduled for a routine adenotonsillectomy
Who cannot join
- Down syndrome
- Craniofacial abnormality
About this study
Official title: Prospective, Controlled Clinical Trial of a Novel Hemostatic Sealant Versus Electrocautery Hemostasis and Coblation Dissection in Patients Undergoing Tonsillectomy
The purpose of this study is to evaluate a new method of hemostasis, floseal gel, in tonsillectomy and adenoidectomy, with the goal of decreasing post operative and intraoperative morbidity.
Read the detailed description
Blood loss and postoperative morbidity following adenotonsillectomy in children can be significant. The current technique for performing a tonsillectomy is "cold steel tonsillectomy" with electocautery hemostasis and a newer technique of coblation tonsillectomy. Postoperative pain has been shown to be increased in patients undergoing extensive electrocautery, with less pain seen in patients undergoing coblation tonsillectomy. The purpose of the study is to evaluate the clinical efficacy and complications of Floseal matrix hemostatic sealant for use in patients undergoing adenotonsillectomy compared with two other currently used techniques.
The study is a prospective, controlled clinical trial comparing Floseal hemostasis in "cold steel" knife dissection tonsillectomy with cautery hemostasis in "cold steel" knife dissection tonsillectomy and coblation tonsillectomy in a pediatric population. All children under the age of 18 without previous documented coagulopathy scheduled to undergo tonsillectomy will be offered enrollment in the study. Informed consent will be obtained from the patient's legal guardian. The goal of this study is to determine if Floseal reduces intraoperative blood loss, time to hemostasis, and postoperative morbidity in patients undergoing tonsillectomy compared with two other commonly used methods. Also, we wish to evaluate the complication rates following Floseal administration compared to those of electrocautery and coblation.
- Being tested
- Floseal tonsillectomy, Coblation tonsillectomy
- Keywords
- Adenotonsillectomy, Coblation tonsillectomy, Floseal
- Medical subject headings
- Tonsillitis, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Floseal tonsillectomyDevice
Coblation tonsillectomyDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative: Procedure time, hemostasis time, difficulty of hemostasis, blood loss
Measured: intraoperative period
Postoperative: Amount of pain medication required (day 1-14), subjective pain score, postoperative day # for returning to a normal diet and normal activity
Measured: postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2007 (estimated)
- Study startJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenotonsillar HypertrophyStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Investigators
- Joshua A Gottschall, M.D., Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459927
- Sponsor's protocol ID
- CN-06JGott-01-B
- Status last verified
- Mar 2014
- First submitted
- 11 Apr 2007
- Last updated
- 19 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Controlled Clinical Trial of a Novel Hemostatic Sealant Versus Electrocautery Hemostasis and Coblation Dissection in Patients Undergoing Tonsillectomy
- ClinicalTrials.gov ID
- NCT00459927
- Acronym / sponsor ID
- CN-06JGott-01-B
- Keywords
- Adenotonsillectomy, Coblation tonsillectomy, Floseal
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Jul 2009
- First posted
- 13 Apr 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 evaluate a new method of hemostasis, floseal gel, in tonsillectomy and adenoidectomy, with the goal of decreasing post operative and intraoperative morbidity.
Detailed description
Blood loss and postoperative morbidity following adenotonsillectomy in children can be significant. The current technique for performing a tonsillectomy is "cold steel tonsillectomy" with electocautery hemostasis and a newer technique of coblation tonsillectomy. Postoperative pain has been shown to be increased in patients undergoing extensive electrocautery, with less pain seen in patients undergoing coblation tonsillectomy. The purpose of the study is to evaluate the clinical efficacy and complications of Floseal matrix hemostatic sealant for use in patients undergoing adenotonsillectomy compared with two other currently used techniques.
The study is a prospective, controlled clinical trial comparing Floseal hemostasis in "cold steel" knife dissection tonsillectomy with cautery hemostasis in "cold steel" knife dissection tonsillectomy and coblation tonsillectomy in a pediatric population. All children under the age of 18 without previous documented coagulopathy scheduled to undergo tonsillectomy will be offered enrollment in the study. Informed consent will be obtained from the patient's legal guardian. The goal of this study is to determine if Floseal reduces intraoperative blood loss, time to hemostasis, and postoperative morbidity in patients undergoing tonsillectomy compared with two other commonly used methods. Also, we wish to evaluate the complication rates following Floseal administration compared to those of electrocautery and coblation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients less than 18 years old scheduled for a routine adenotonsillectomy
Key exclusion criteria (2 listed)
- Down syndrome
- Craniofacial abnormality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Floseal tonsillectomy | Device | – |
| Coblation tonsillectomy | Device | – |
Primary outcome
Intraoperative: Procedure time, hemostasis time, difficulty of hemostasis, blood loss
Time frame: intraoperative period
Postoperative: Amount of pain medication required (day 1-14), subjective pain score, postoperative day # for returning to a normal diet and normal activity
Time frame: postoperative period
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2014.
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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.
Joshua A Gottschall, M.D. principal investigator
Kaiser Permanente
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Floseal tonsillectomy and Coblation tonsillectomy in people with Adenotonsillar Hypertrophy and Tonsillitis, run by Kaiser Permanente.
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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 19 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Intraoperative: Procedure time, hemostasis time, difficulty of hemostasis, blood loss (time frame: intraoperative period). The study lists 2 primary outcomes in all. 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 19 Mar 2014.