Tonsil DiseaseBCB-TonsillectNCT07395193
Comparative Evaluation of BiZact™, Coblation, and Bipolar Tonsillectomy Techniques
An observational study of Tonsil Disease and Tonsil Disorder, run by Medicana Bursa Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective, non-randomized observational study compared the surgical outcomes of BiZact™, Coblation, and Bipolar tonsillectomy techniques in pediatric and adult patients. Operative efficiency, postoperative pain, recovery parameters, postoperative bleeding, and device-related costs were evaluated. Read more about this study
- Who is it for?
- Ages 5 to 40 years
- Conditions the study is for
- Tonsil Disease, Tonsil Disorder
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Nov 2024to 29 Sep 2025
- 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 5 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric and adult patients undergoing tonsillectomy at a tertiary care center.
Who may be able to join
- Age between 5 and 40 years
- Undergoing tonsillectomy
- Indication for surgery due to recurrent tonsillitis or obstructive sleep-related symptoms
Who cannot join
- Known coagulation disorders
- Presence of peritonsillar abscess
- Presence of craniofacial syndromes
- Incomplete follow-up data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Observational Study Comparing BiZact™, Coblation, and Bipolar Tonsillectomy Techniques
This prospective, non-randomized observational study compared the surgical outcomes of BiZact™, Coblation, and Bipolar tonsillectomy techniques in pediatric and adult patients. Operative efficiency, postoperative pain, recovery parameters, postoperative bleeding, and device-related costs were evaluated.
Read the detailed description
Tonsillectomy is a commonly performed surgical procedure in otorhinolaryngology, and various techniques have been developed to improve operative efficiency and postoperative recovery. This prospective, non-randomized observational study included 150 patients aged 5-40 years who underwent tonsillectomy between November 2024 and September 2025. Patients were allocated to Bipolar, Coblation, or BiZact tonsillectomy groups based on surgeon preference and device availability.
Primary outcome measures were operative time and postoperative pain assessed using the visual analogue scale on postoperative days 1, 3, and 7. Secondary outcomes included time to first solid food intake, length of hospital stay, postoperative bleeding, bleeding management, and device-related cost. The study aimed to compare clinical outcomes, recovery profiles, and procedural efficiency among the three tonsillectomy techniques.
- Conditions
- Tonsil Disease, Tonsil Disorder
- Keywords
- tonsillectomy
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 |
|---|---|---|
| BiZact Tonsillectomy | Patients undergoing tonsillectomy using the BiZact™ device. | |
| Coblation Tonsillectomy | Patients undergoing tonsillectomy using the coblation technique. | |
| Bipolar Tonsillectomy | Patients undergoing tonsillectomy using bipolar electrocautery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain (Visual Analog Scale score)
Postoperative pain was assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores represent greater pain intensity.
Measured: Postoperative days 1, 3, and 7
Surgery time
Measured: During surgery
Secondary outcomes (4)
Time to first solid food intake
Measured: Within the first postoperative week
Length of hospital stay
Duration of hospitalization measured in days following tonsillectomy.
Measured: Postoperative Day 1
Postoperative bleeding
Measured: Up to 30 days postoperatively
Device cost per case
Cost of the surgical device used for tonsillectomy, calculated per patient.
Measured: Perioperative period (day of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start29 Nov 2024
- Primary completion29 Sep 2025
- Study completion29 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tonsil DiseaseStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicana Bursa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oktay Bulut, Medicana Bursa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395193
- Sponsor's protocol ID
- 2024/2
- Acronym
- BCB-Tonsillect
- Status last verified
- Feb 2026
- First submitted
- 27 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bulut O, et al. Comparative Evaluation of BiZact™, Coblation, and Bipolar Tonsillectomy Techniques. Unpublished data.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study Comparing BiZact™, Coblation, and Bipolar Tonsillectomy Techniques
- ClinicalTrials.gov ID
- NCT07395193
- Acronym / sponsor ID
- BCB-Tonsillect / 2024/2
- Conditions
- Tonsil Disease, Tonsil Disorder
- Keywords
- tonsillectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Medicana Bursa HospitalUniversity, hospital or other
- Study start
- 29 Nov 2024 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 9 Feb 2026 (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 prospective, non-randomized observational study compared the surgical outcomes of BiZact™, Coblation, and Bipolar tonsillectomy techniques in pediatric and adult patients. Operative efficiency, postoperative pain, recovery parameters, postoperative bleeding, and device-related costs were evaluated.
Detailed description
Tonsillectomy is a commonly performed surgical procedure in otorhinolaryngology, and various techniques have been developed to improve operative efficiency and postoperative recovery. This prospective, non-randomized observational study included 150 patients aged 5-40 years who underwent tonsillectomy between November 2024 and September 2025. Patients were allocated to Bipolar, Coblation, or BiZact tonsillectomy groups based on surgeon preference and device availability.
Primary outcome measures were operative time and postoperative pain assessed using the visual analogue scale on postoperative days 1, 3, and 7. Secondary outcomes included time to first solid food intake, length of hospital stay, postoperative bleeding, bleeding management, and device-related cost. The study aimed to compare clinical outcomes, recovery profiles, and procedural efficiency among the three tonsillectomy techniques.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BiZact Tonsillectomy | – | –Patients undergoing tonsillectomy using the BiZact™ device. |
| Coblation Tonsillectomy | – | –Patients undergoing tonsillectomy using the coblation technique. |
| Bipolar Tonsillectomy | – | –Patients undergoing tonsillectomy using bipolar electrocautery. |
Who may qualify
- Ages
- 5 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric and adult patients undergoing tonsillectomy at a tertiary care center.
Key inclusion criteria (3 listed)
- Age between 5 and 40 years
- Undergoing tonsillectomy
- Indication for surgery due to recurrent tonsillitis or obstructive sleep-related symptoms
Key exclusion criteria (4 listed)
- Known coagulation disorders
- Presence of peritonsillar abscess
- Presence of craniofacial syndromes
- Incomplete follow-up data
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
Postoperative pain (Visual Analog Scale score)
Time frame: Postoperative days 1, 3, and 7
Postoperative pain was assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores represent greater pain intensity.
Surgery time
Time frame: During surgery
4 secondary outcomes
Time to first solid food intake
Time frame: Within the first postoperative week
Length of hospital stay
Time frame: Postoperative Day 1
Postoperative bleeding
Time frame: Up to 30 days postoperatively
Device cost per case
Time frame: Perioperative period (day of surgery)
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 10 Feb 2026.
- Results publicationBulut O, et al. Comparative Evaluation of BiZact™, Coblation, and Bipolar Tonsillectomy Techniques. Unpublished data.
- 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?
An observational study of Tonsil Disease and Tonsil Disorder, run by Medicana Bursa Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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 10 Feb 2026. 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 Turkey (Türkiye). 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?
Postoperative pain (Visual Analog Scale score) (time frame: Postoperative days 1, 3, and 7). 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 NCT07395193, which also lists 1 linked publication.
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 10 Feb 2026.