An interventional study of BiZact and Standard of care in Tonsillectomy, Tonsillitis Chronic and Hemorrhage, sponsored by Baylor College of Medicine. Completed at 1 site in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2024-07-29.
Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Treatment
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Among 32 studies in Postoperative Hemorrhage with a site in United States — 9 open to participants now, 9 under way, 2 of them phase 3. Postoperative Hemorrhage · United States.
Among the 32 studies in Postoperative Hemorrhage with a site in United States, this one is the 9th largest by enrollment of the 28 interventional ones that give a count, is one of 5 that started in 2021, is one of 12 with no phase, and was the 20th registered.
135 studies on the registry are indexed under Postoperative Hemorrhage; 31 are open to participants now.
Browse Postoperative Hemorrhage studies →9 of the 32 studies in Postoperative Hemorrhage with a site in United States are open now. Recruiting first, the newest first:
University of Michigan · Sites in United States
Ages 18+ · Women only
Women and Infants Hospital of Rhode Island · Sites in United States
Ages 18+ · Women only
Vanderbilt University Medical Center · Sites in United States
Ages 18+ · Healthy volunteers
Vanderbilt University Medical Center · Sites in United States
Ages 18+ · Healthy volunteers
University of Colorado, Denver · Sites in United States
Ages 18–90
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 17 Postoperative Hemorrhage studies recruiting now, 11 (65%) set no upper age limit and 4 (24%) stop at 75 or younger; 2 take children under 18; 6 take healthy volunteers.
This study: Up to 18 Years · all sexes · no healthy volunteers.
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32 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 5 · Phase 3 7 · Phase 4 3
First in 2000; this study’s year is marked. 5 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 144 is above the median of 100 across 102 interventional studies indexed under Postoperative Hemorrhage.
Median enrollment 108 across the 28 interventional studies, 100 across the 3 observational. Of the 19 that completed or were terminated, 8 (42%) have results posted.
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8 of 32 have an industry lead sponsor. The 10 most frequent:
Baylor College of Medicine is the lead sponsor of 747 studies on the registry; 110 are open to participants now.
Of its 84 completed or terminated interventional studies of FDA-regulated products, 45 (54%) have results posted.
Baylor College of Medicine has 1 study filed under Postoperative Hemorrhage — fewer than ten, so there is no comparison to draw.
3 of the studies in Postoperative Hemorrhage with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07826637Hemorai IncStudy of the Hemorai Vysio Wearable Device for Monitoring Changes Related to Blood Loss in Patients During and After Surgery. | 2027-05-01 |
| NCT06450834University of Maryland, BaltimoreOstene in Thoracolumbar Decompression and Fusion Evaluated With VIBE | 2027-06 |
| NCT06057675Vanderbilt University Medical CenterTranexamic Acid in Nasal Mohs Reconstruction | 2027-08 |
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Among the 32 studies in Postoperative Hemorrhage with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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
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:
135 studies on the registry are indexed under Postoperative Hemorrhage; 31 are open to participants now.
This study's enrollment of 144 is above the median of 100 across 102 interventional studies indexed under Postoperative Hemorrhage.
Browse Postoperative Hemorrhage studies →Baylor College of Medicine is the lead sponsor of 747 studies on the registry; 110 are open to participants now.
Of its 84 completed or terminated interventional studies of FDA-regulated products, 45 (54%) have results posted.
Compared within Postoperative Hemorrhage, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hemorrhage. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
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
Device: BiZact
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
Procedure: Standard of care
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
This method would involve removal of tonsils using electrocautery technique
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.
Time frame: 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.
Time frame: Duration of surgery
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Duration of procedure
Plan to share: No
Ran from Jun 2021 to primary completion in Jul 2024, 37 months.
Of 35 non-industry interventional studies with no phase under Postoperative Hemorrhage, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 23. This study's 37 months is above that.
Counting every sponsor, half of 38 studies reached it within 14 months; a quarter within 8 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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