TonsillectomyNCT04725305
BiZact Tonsillectomy in the Pediatric Population
A study testing BiZact in people with Tonsillectomy and Tonsillitis Chronic, run by Baylor College of Medicine at 1 site in United States.
Trial summary
This study has been designed to evaluate how effective the Bizact tonsillectomy device is in reducing operating time and complications that occur after surgery. This device operates in a different way than the standard device that is used for most tonsillectomies. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Tonsillectomy, Tonsillitis Chronic, Hemorrhage
- What is being tested?
- BiZact
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2021to 25 Jul 2024
- Phase
- Interventional
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Tonsil hypertrophy with sleep disordered breathing
- Recurrent tonsillitis or pharyngitis
- Tonsil asymmetry or neoplasm
- Tonsil stones
- Must be able to take ibuprofen
Who cannot join
- Bleeding disorders such as von Willebrand's disease or hemophilia
- Down's Syndrome or other craniofacial syndromes
- Revision tonsillectomy cases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BiZact Tonsillectomy
This study has been designed to evaluate how effective the Bizact tonsillectomy device is in reducing operating time and complications that occur after surgery. This device operates in a different way than the standard device that is used for most tonsillectomies. In 2019, a study was conducted in 186 children and adults using this device in tonsillectomies. Results showed lower blood loss and shortened time in surgery. However, the rate for bleeding as a complication after surgery was the same as other procedures that are used in tonsillectomy
Read the detailed description
Tonsillectomy is the second most common pediatric surgical procedure, with more than 280,000 performed in children under the age of 15 in the United States in 2010. The most common indications for tonsillectomy in children include recurrent infections and obstructive sleep apnea. While tonsillectomy in the pediatric population is generally safe and well-tolerated, post-operative complications are not uncommon, with post-operative pain, respiratory compromise, and post-tonsillectomy hemorrhage being chief among them.
Post-operative pain has been described as the main morbidity associated with tonsillectomy and is often ineffectively controlled. Pain beyond the initial 24-hour post-operative period has been noted to be worse with the use of electrocautery when compared to cold-knife dissection and snare tonsillectomy, perhaps attributable to the high levels of heat (400 °C to 600 °C) applied directly to the tonsillar area. Yet electrocautery remains one of the most frequently utilized tools due to its hemostatic effects through vessel coagulation at the time of dissection. Still, a recent large meta-analysis reported the rates of primary post-tonsillectomy hemorrhage (bleeding within the first 24 hours) at 2.4% and secondary post-tonsillectomy hemorrhage (beyond 24 hours) at 2.6%, suggesting that bleeding after tonsillectomy remains a relatively common occurrence. The search for a methodology that improves post-operative pain without increasing the risk of post-operative hemorrhage remains an active area of research.
Coblation, which creates an ionized plasma layer by passing a bipolar radio-frequency current through a medium of saline, offers another approach. The saline irrigation results in much less heat when compared to monopolar cautery, measuring approximately 40°C to 70°C. Coblation can be used in both subcapsular and intracapsular fashion. Subcapsular tonsillectomy with coblation has demonstrated a minimal decrease in pain, and may result in slightly higher rates of post-operative hemorrhage.
It has been pointed out that bipolar cautery could result in lower thermal injury and reduced blood loss, however tonsillectomy using traditional bipolar forceps leads to longer operative times. One group found that the use of BiClamp, a bipolar vascular sealing device originally designed for thyroidectomy, provided decreased operative times and less intraoperative bleeding compared to electrocautery. They noted, however, instances of posterior pillar perforation, which they attributed to curvature of the device that was designed for thyroid surgery, making dissection of the superior pole more difficult. Medtronic has now developed a similar device designed for use in tonsillectomy with a curved jaw meant to follow the contour of the tonsillar bed. In its marketing material for the recently developed BiZact , Medtronic describes a bipolar device that continuously measures the impedance of clamped tissue, adjusting energy levels in real-time and automatically stopping energy delivery when a seal is established. Their literature suggests the device permanently seals vessels up to 3mm with less thermal damage, resulting in less intraoperative blood loss, more efficient procedures, and possibly less pain.
In a pilot study of 186 patients, intraoperative blood loss was shown to be <1ml of blood loss in 71 cases (38.2%) and between 1 and 10ml of blood loss in 81 cases (43.5%). Post-operative hemorrhage rate of 4.3% is similar to rates described by other studies. BiZact tonsillectomy allows for a shortened operative time with a median time of 5.1 minutes. Other studies have shown other techniques to have a time duration of 21.6 minutes (electrocautery), 20.20 minutes (coblator), and 16.14 minutes (microdebrider).
In off label use of the device at our institution, data from surgeons using the device showed that surgeons perceived a relative improvement in following compared to standard tonsillectomy:
- Less perceived thermal heat transfer to surrounding soft tissues
- Left perceived blood loss
- Superior ease of obtaining timely hemostasis
- Faster operative time
- Conditions
- Tonsillectomy, Tonsillitis Chronic, Hemorrhage, Postoperative Pain, Postoperative Hemorrhage, Surgery--Complications
- Being tested
- BiZact, Standard of care
- Keywords
- tonsillectomy, Bizact
- Medical subject headings
- Hemorrhage, Pain, Postoperative, Postoperative Hemorrhage, Otorhinolaryngologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiZactDevice
It has been described as describes a bipolar device that continuously measures impedance of clamped tissue, adjusting energy levels in real time and automatically stopping energy delivery when a seal is established. Their literature suggests the device permanently seals vessels up to 3mm with less thermal damage, resulting in less intraoperative blood loss, more efficient procedures, and possibly less pain
Standard of careProcedure or surgery
This method would involve removal of tonsils using electrocautery technique
| Study group | Role | What they receive |
|---|---|---|
| BiZact | Experimental | A bipolar electrosurgical device that employs radiofrequency(RF) energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger Receives: Device: BiZact |
| Standard of care | Active comparator | In electrocautery tonsillectomy (or diathermy) electric current from a radiofrequency generator is passed through the tissue between two electrodes. The resulting high temperature (400º-600ºC) cuts the tissue and simultaneously seals the blood vessels Receives: Procedure: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency room visits
Emergency room visits following tonsillectomy commonly involve poorly controlled pain, dehydration, and post-tonsillectomy hemorrhage. The investigators will tabulate the number of ER visits related to post-operative factors by reviewing charts of tonsillectomy patients two months post-operatively.
Measured: 2 months
Intra-operative blood loss
Intra-operative blood loss will be recorded in milliliters for all patients undergoing tonsillectomy using the BiZact device. Additionally, each surgeon using the Bi-zact device will maintain records of intra-operative blood loss in milliliters for tonsillectomies utilizing standard electrocautery for tonsillectomy.
Measured: Duration of surgery
Secondary outcomes (4)
Post-tonsillectomy hemorrhage
Post-tonsillectomy hemorrhage is a known complication of tonsillectomy. The investigators will tabulate the incidence of post-tonsillectomy hemorrhage by reviewing emergency room visits in the post-operative period and through follow-up questionnaires at the first post-operative clinic visit.
Measured: 2 months
Pain level
Patients will be asked to maintain a pain diary. The investigators will ask the parent or caretaker to document the Wong-Baker FACES Pain Rating Scale twice a day for fourteen days.
Measured: 14 days
Pain medication documentation
Post-operative pain protocol at Texas Children's Hospital includes scheduled weight-based doses of ibuprofen every 6 hours for 5 days, acetaminophen every 4-6 hours as needed, and a one-time dose of dexamethasone as needed to be given on post-operative day 3, 4, or 5 for breakthrough pain. Patients are also instructed to use ibuprofen as needed for pain after the first 5 days. Participants will be instructed to maintain accurate records of use of acetaminophen and dexamethasone use, and use of ibuprofen beyond 5 days post-operatively
Measured: 5 days
Operating time
Operative time in minutes will be recorded for all patients undergoing tonsillectomy using the BiZact device. Additionally, each surgeon using the BiZact device will maintain records of operative time using standard electrocautery for tonsillectomy
Measured: Duration of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start6 Jun 2021
- Primary completion25 Jul 2024
- Study completion25 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for TonsillectomyStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups of participants will receive different interventions. One arm will receive the standard of care ( electrocautery) and the other group will receive the BIZACT method of tonsillectomy. The group allocation will be carried out by stratified randomization.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald Vilela, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725305
- Sponsor's protocol ID
- H-44399
- Status last verified
- Jul 2024
- First submitted
- 26 Nov 2020
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hall MJ, Schwartzman A, Zhang J, Liu X. Ambulatory Surgery Data From Hospitals and Ambulatory Surgery Centers: United States, 2010. Natl Health Stat Report. 2017 Feb;(102):1-15.
PubMed 28256998Rosenfeld RM, Green RP. Tonsillectomy and adenoidectomy: changing trends. Ann Otol Rhinol Laryngol. 1990 Mar;99(3 Pt 1):187-91.
PubMed 2178542De Luca Canto G, Pacheco-Pereira C, Aydinoz S, Bhattacharjee R, Tan HL, Kheirandish-Gozal L, Flores-Mir C, Gozal D. Adenotonsillectomy Complications: A Meta-analysis. Pediatrics. 2015 Oct;136(4):702-18. doi: 10.1542/peds.2015-1283. Epub 2015 Sep 21.
PubMed 26391937Baugh RF, Archer SM, Mitchell RB, Rosenfeld RM, Amin R, Burns JJ, Darrow DH, Giordano T, Litman RS, Li KK, Mannix ME, Schwartz RH, Setzen G, Wald ER, Wall E, Sandberg G, Patel MM; American Academy of Otolaryngology-Head and Neck Surgery Foundation. Clinical practice guideline: tonsillectomy in children. Otolaryngol Head Neck Surg. 2011 Jan;144(1 Suppl):S1-30. doi: 10.1177/0194599810389949.
PubMed 21493257Nunez DA, Provan J, Crawford M. Postoperative tonsillectomy pain in pediatric patients: electrocautery (hot) vs cold dissection and snare tonsillectomy--a randomized trial. Arch Otolaryngol Head Neck Surg. 2000 Jul;126(7):837-41. doi: 10.1001/archotol.126.7.837.
PubMed 10888995Jones DT, Kenna MA, Guidi J, Huang L, Johnston PR, Licameli GR. Comparison of postoperative pain in pediatric patients undergoing coblation tonsillectomy versus cautery tonsillectomy. Otolaryngol Head Neck Surg. 2011 Jun;144(6):972-7. doi: 10.1177/0194599811400369. Epub 2011 Apr 4.
PubMed 21493315Heidemann CH, Wallen M, Aakesson M, Skov P, Kjeldsen AD, Godballe C. Post-tonsillectomy hemorrhage: assessment of risk factors with special attention to introduction of coblation technique. Eur Arch Otorhinolaryngol. 2009 Jul;266(7):1011-5. doi: 10.1007/s00405-008-0834-2. Epub 2008 Oct 25.
PubMed 18953553Lee SW, Jeon SS, Lee JD, Lee JY, Kim SC, Koh YW. A comparison of postoperative pain and complications in tonsillectomy using BiClamp forceps and electrocautery tonsillectomy. Otolaryngol Head Neck Surg. 2008 Aug;139(2):228-34. doi: 10.1016/j.otohns.2008.04.004.
PubMed 18656720Pizzuto MP, Brodsky L, Duffy L, Gendler J, Nauenberg E. A comparison of microbipolar cautery dissection to hot knife and cold knife cautery tonsillectomy. Int J Pediatr Otorhinolaryngol. 2000 May 30;52(3):239-46. doi: 10.1016/s0165-5876(00)00293-7.
PubMed 10841953Medtronic Brief: More efficient tonsillectomies. Boulder Colorado, 2017. Retrieved from http://www.medtronic.com/content/dam/covidien/library/us/en/product/vessel-sealing/bizact-tonsillectomy-device-product-information-kit.pdf, 9/23/18.
Krishnan G, Stepan L, Du C, Padhye V, Bassiouni A, Dharmawardana N, Ooi EH, Krishnan S. Tonsillectomy using the BiZact: A pilot study in 186 children and adults. Clin Otolaryngol. 2019 May;44(3):392-396. doi: 10.1111/coa.13273. Epub 2019 Feb 4. No abstract available.
PubMed 30576062
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BiZact Tonsillectomy
- ClinicalTrials.gov ID
- NCT04725305
- Acronym / sponsor ID
- H-44399
- Conditions
- Tonsillectomy, Tonsillitis Chronic, Hemorrhage, Postoperative Pain, Postoperative Hemorrhage, Surgery--Complications
- Keywords
- tonsillectomy, Bizact
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 6 Jun 2021 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 26 Jan 2021 (actual)
- 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.
This study has been designed to evaluate how effective the Bizact tonsillectomy device is in reducing operating time and complications that occur after surgery. This device operates in a different way than the standard device that is used for most tonsillectomies. In 2019, a study was conducted in 186 children and adults using this device in tonsillectomies. Results showed lower blood loss and shortened time in surgery. However, the rate for bleeding as a complication after surgery was the same as other procedures that are used in tonsillectomy
Detailed description
Tonsillectomy is the second most common pediatric surgical procedure, with more than 280,000 performed in children under the age of 15 in the United States in 2010. The most common indications for tonsillectomy in children include recurrent infections and obstructive sleep apnea. While tonsillectomy in the pediatric population is generally safe and well-tolerated, post-operative complications are not uncommon, with post-operative pain, respiratory compromise, and post-tonsillectomy hemorrhage being chief among them.
Post-operative pain has been described as the main morbidity associated with tonsillectomy and is often ineffectively controlled. Pain beyond the initial 24-hour post-operative period has been noted to be worse with the use of electrocautery when compared to cold-knife dissection and snare tonsillectomy, perhaps attributable to the high levels of heat (400 °C to 600 °C) applied directly to the tonsillar area. Yet electrocautery remains one of the most frequently utilized tools due to its hemostatic effects through vessel coagulation at the time of dissection. Still, a recent large meta-analysis reported the rates of primary post-tonsillectomy hemorrhage (bleeding within the first 24 hours) at 2.4% and secondary post-tonsillectomy hemorrhage (beyond 24 hours) at 2.6%, suggesting that bleeding after tonsillectomy remains a relatively common occurrence. The search for a methodology that improves post-operative pain without increasing the risk of post-operative hemorrhage remains an active area of research.
Coblation, which creates an ionized plasma layer by passing a bipolar radio-frequency current through a medium of saline, offers another approach. The saline irrigation results in much less heat when compared to monopolar cautery, measuring approximately 40°C to 70°C. Coblation can be used in both subcapsular and intracapsular fashion. Subcapsular tonsillectomy with coblation has demonstrated a minimal decrease in pain, and may result in slightly higher rates of post-operative hemorrhage.
It has been pointed out that bipolar cautery could result in lower thermal injury and reduced blood loss, however tonsillectomy using traditional bipolar forceps leads to longer operative times. One group found that the use of BiClamp, a bipolar vascular sealing device originally designed for thyroidectomy, provided decreased operative times and less intraoperative bleeding compared to electrocautery. They noted, however, instances of posterior pillar perforation, which they attributed to curvature of the device that was designed for thyroid surgery, making dissection of the superior pole more difficult. Medtronic has now developed a similar device designed for use in tonsillectomy with a curved jaw meant to follow the contour of the tonsillar bed. In its marketing material for the recently developed BiZact , Medtronic describes a bipolar device that continuously measures the impedance of clamped tissue, adjusting energy levels in real-time and automatically stopping energy delivery when a seal is established. Their literature suggests the device permanently seals vessels up to 3mm with less thermal damage, resulting in less intraoperative blood loss, more efficient procedures, and possibly less pain.
In a pilot study of 186 patients, intraoperative blood loss was shown to be <1ml of blood loss in 71 cases (38.2%) and between 1 and 10ml of blood loss in 81 cases (43.5%). Post-operative hemorrhage rate of 4.3% is similar to rates described by other studies. BiZact tonsillectomy allows for a shortened operative time with a median time of 5.1 minutes. Other studies have shown other techniques to have a time duration of 21.6 minutes (electrocautery), 20.20 minutes (coblator), and 16.14 minutes (microdebrider).
In off label use of the device at our institution, data from surgeons using the device showed that surgeons perceived a relative improvement in following compared to standard tonsillectomy:
- Less perceived thermal heat transfer to surrounding soft tissues
- Left perceived blood loss
- Superior ease of obtaining timely hemostasis
- Faster operative time
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two groups of participants will receive different interventions. One arm will receive the standard of care ( electrocautery) and the other group will receive the BIZACT method of tonsillectomy. The group allocation will be carried out by stratified randomization.
| Arm | Type | Receives |
|---|---|---|
| BiZact | Experimental | Device: BiZactA bipolar electrosurgical device that employs radiofrequency(RF) energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger |
| Standard of care | Active comparator | Procedure: Standard of careIn electrocautery tonsillectomy (or diathermy) electric current from a radiofrequency generator is passed through the tissue between two electrodes. The resulting high temperature (400º-600ºC) cuts the tissue and simultaneously seals the blood vessels |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Tonsil hypertrophy with sleep disordered breathing
- Recurrent tonsillitis or pharyngitis
- Tonsil asymmetry or neoplasm
- Tonsil stones
- Must be able to take ibuprofen
Key exclusion criteria (3 listed)
- Bleeding disorders such as von Willebrand's disease or hemophilia
- Down's Syndrome or other craniofacial syndromes
- Revision tonsillectomy cases
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 |
|---|---|---|
| BiZactIt has been described as describes a bipolar device that continuously measures impedance of clamped tissue, adjusting energy levels in real time and automatically stopping energy delivery when a seal is established. Their literature suggests the device permanently seals vessels up to 3mm with less thermal damage, resulting in less intraoperative blood loss, more efficient procedures, and possibly less pain | Device | BiZact |
| Standard of careThis method would involve removal of tonsils using electrocautery technique | Procedure or surgery | Standard of care |
Primary outcome
Emergency room visits
Time frame: 2 months
Emergency room visits following tonsillectomy commonly involve poorly controlled pain, dehydration, and post-tonsillectomy hemorrhage. The investigators will tabulate the number of ER visits related to post-operative factors by reviewing charts of tonsillectomy patients two months post-operatively.
Intra-operative blood loss
Time frame: Duration of surgery
Intra-operative blood loss will be recorded in milliliters for all patients undergoing tonsillectomy using the BiZact device. Additionally, each surgeon using the Bi-zact device will maintain records of intra-operative blood loss in milliliters for tonsillectomies utilizing standard electrocautery for tonsillectomy.
4 secondary outcomes
Post-tonsillectomy hemorrhage
Time frame: 2 months
Pain level
Time frame: 14 days
Pain medication documentation
Time frame: 5 days
Operating time
Time frame: Duration of procedure
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 29 Jul 2024.
- Background: PubMed 28256998Hall MJ, Schwartzman A, Zhang J, Liu X. Ambulatory Surgery Data From Hospitals and Ambulatory Surgery Centers: United States, 2010. Natl Health Stat Report. 2017 Feb;(102):1-15.
- Background: PubMed 2178542Rosenfeld RM, Green RP. Tonsillectomy and adenoidectomy: changing trends. Ann Otol Rhinol Laryngol. 1990 Mar;99(3 Pt 1):187-91.
- Background: PubMed 26391937De Luca Canto G, Pacheco-Pereira C, Aydinoz S, Bhattacharjee R, Tan HL, Kheirandish-Gozal L, Flores-Mir C, Gozal D. Adenotonsillectomy Complications: A Meta-analysis. Pediatrics. 2015 Oct;136(4):702-18. doi: 10.1542/peds.2015-1283. Epub 2015 Sep 21.
- Background: PubMed 21493257Baugh RF, Archer SM, Mitchell RB, Rosenfeld RM, Amin R, Burns JJ, Darrow DH, Giordano T, Litman RS, Li KK, Mannix ME, Schwartz RH, Setzen G, Wald ER, Wall E, Sandberg G, Patel MM; American Academy of Otolaryngology-Head and Neck Surgery Foundation. Clinical practice guideline: tonsillectomy in children. Otolaryngol Head Neck Surg. 2011 Jan;144(1 Suppl):S1-30. doi: 10.1177/0194599810389949.
- Background: PubMed 10888995Nunez DA, Provan J, Crawford M. Postoperative tonsillectomy pain in pediatric patients: electrocautery (hot) vs cold dissection and snare tonsillectomy--a randomized trial. Arch Otolaryngol Head Neck Surg. 2000 Jul;126(7):837-41. doi: 10.1001/archotol.126.7.837.
- Background: PubMed 21493315Jones DT, Kenna MA, Guidi J, Huang L, Johnston PR, Licameli GR. Comparison of postoperative pain in pediatric patients undergoing coblation tonsillectomy versus cautery tonsillectomy. Otolaryngol Head Neck Surg. 2011 Jun;144(6):972-7. doi: 10.1177/0194599811400369. Epub 2011 Apr 4.
- Background: PubMed 18953553Heidemann CH, Wallen M, Aakesson M, Skov P, Kjeldsen AD, Godballe C. Post-tonsillectomy hemorrhage: assessment of risk factors with special attention to introduction of coblation technique. Eur Arch Otorhinolaryngol. 2009 Jul;266(7):1011-5. doi: 10.1007/s00405-008-0834-2. Epub 2008 Oct 25.
- Background: PubMed 18656720Lee SW, Jeon SS, Lee JD, Lee JY, Kim SC, Koh YW. A comparison of postoperative pain and complications in tonsillectomy using BiClamp forceps and electrocautery tonsillectomy. Otolaryngol Head Neck Surg. 2008 Aug;139(2):228-34. doi: 10.1016/j.otohns.2008.04.004.
- Background: PubMed 10841953Pizzuto MP, Brodsky L, Duffy L, Gendler J, Nauenberg E. A comparison of microbipolar cautery dissection to hot knife and cold knife cautery tonsillectomy. Int J Pediatr Otorhinolaryngol. 2000 May 30;52(3):239-46. doi: 10.1016/s0165-5876(00)00293-7.
- BackgroundMedtronic Brief: More efficient tonsillectomies. Boulder Colorado, 2017. Retrieved from http://www.medtronic.com/content/dam/covidien/library/us/en/product/vessel-sealing/bizact-tonsillectomy-device-product-information-kit.pdf, 9/23/18.
- Background: PubMed 30576062Krishnan G, Stepan L, Du C, Padhye V, Bassiouni A, Dharmawardana N, Ooi EH, Krishnan S. Tonsillectomy using the BiZact: A pilot study in 186 children and adults. Clin Otolaryngol. 2019 May;44(3):392-396. doi: 10.1111/coa.13273. Epub 2019 Feb 4. No abstract available.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BiZact in people with Tonsillectomy and Tonsillitis Chronic, run by Baylor College of Medicine at 1 site 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 5 inclusion and 3 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 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Emergency room visits (time frame: 2 months). 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?
On the ClinicalTrials.gov record for NCT04725305, which also lists 11 linked publications.
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 29 Jul 2024.