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CompletedNCT07395193BCB-TonsillectUpdated Feb 10, 2026

Comparative Evaluation of BiZact™, Coblation, and Bipolar Tonsillectomy Techniques

An observational study in Tonsil Disease and Tonsil Disorder, sponsored by Medicana Bursa Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 5 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-02-10.

Sponsored by Medicana Bursa Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
5 Years to 40 Years
Sex
All
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Study 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 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.

02

Conditions studied

  • Tonsil Disease
  • Tonsil Disorder

Keywords

  • tonsillectomy
03

In context

Lead sponsor

This is the only study on the registry with Medicana Bursa Hospital as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
5 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pediatric and adult patients undergoing tonsillectomy at a tertiary care center.

Inclusion criteria

  • Age between 5 and 40 years
  • Undergoing tonsillectomy
  • Indication for surgery due to recurrent tonsillitis or obstructive sleep-related symptoms

Exclusion criteria

Exclusion Criteria:

  • Known coagulation disorders
  • Presence of peritonsillar abscess
  • Presence of craniofacial syndromes
  • Incomplete follow-up data
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Postoperative days 1, 3, and 7

  2. Surgery time

    Time frame: During surgery

Secondary outcomes

  1. Time to first solid food intake

    Time frame: Within the first postoperative week

  2. Length of hospital stay

    Duration of hospitalization measured in days following tonsillectomy.

    Time frame: Postoperative Day 1

  3. Postoperative bleeding

    Time frame: Up to 30 days postoperatively

  4. Device cost per case

    Cost of the surgical device used for tonsillectomy, calculated per patient.

    Time frame: Perioperative period (day of surgery)

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Study locations

1 site
  • Medicana Bursa Hospital
    Nilufer, Bursa, Turkey (Türkiye)
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References and documents

Publications

  • Bulut O, et al. Comparative Evaluation of BiZact™, Coblation, and Bipolar Tonsillectomy Techniques. Unpublished data.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07395193
Lead sponsor
Medicana Bursa Hospital
Responsible party
Oktay Bulut (Principal Investigator, Medicana Bursa Hospital) — Principal investigator
First posted
Feb 9, 2026
Start date
Nov 29, 2024
Primary completion
Sep 29, 2025
Completion
Sep 29, 2025
Last update
Feb 10, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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