NCT07395193

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 29, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

10 months

First QC Date

January 27, 2026

Last Update Submit

February 8, 2026

Conditions

Tonsil DiseaseTonsil Disorder

Keywords

tonsillectomy

Outcome Measures

Primary Outcomes (2)

  • 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.

    Postoperative days 1, 3, and 7

  • Surgery time

    During surgery

Secondary Outcomes (4)

  • Time to first solid food intake

    Within the first postoperative week

  • Length of hospital stay

    Postoperative Day 1

  • Postoperative bleeding

    Up to 30 days postoperatively

  • Device cost per case

    Perioperative period (day of surgery)

Study Arms (3)

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.

Eligibility Criteria

Age5 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medicana Bursa Hospital

Nilufer, Bursa, Turkey (Türkiye)

Location

Related Publications (1)

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

    RESULT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 9, 2026

Study Start

November 29, 2024

Primary Completion

September 29, 2025

Study Completion

September 29, 2025

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)