NCT07372248

Brief Summary

Cervical transformation zone excision is commonly used in the diagnosis and treatment of cervical intraepithelial neoplasia. Thermal artifacts can negatively affect histopathological evaluation. This study compares three different modifications of conization performed using electrosurgery in terms of the degree of thermal artifacts.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress24%
Feb 2026Dec 2026

First Submitted

Initial submission to the registry

January 5, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
26 days until next milestone

Study Start

First participant enrolled

February 23, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Expected
Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

January 5, 2026

Last Update Submit

February 26, 2026

Conditions

Cervix NeoplasmCervix, Dysplasia

Keywords

conization

Outcome Measures

Primary Outcomes (1)

  • Thermal Artefact

    Thermal artifact will be assessed by blinded gynecologic pathologists using a structured histopathological evaluation based on epithelial distortion, coagulative necrosis, and interference with margin interpretation. Thermal artifact severity will be graded as none, mild, moderate, or severe.

    Within 7 days following the surgical procedure

Secondary Outcomes (1)

  • TZ evaluation

    postoperative 4th month

Study Arms (3)

Pure Cut

ACTIVE COMPARATOR

Conization with Electrosurgery: Power Setting 50 watts pure cut

Procedure: Conization with Electrosurgery diffferent power settings

Blend

ACTIVE COMPARATOR

Conization with Electrosurgery:Power Setting 50 watts blend

Procedure: Conization with Electrosurgery diffferent power settings

Hybrid

EXPERIMENTAL

Conization with Electrosurgery and Knife: Power Setting 50 watts pure cut and knife

Procedure: Conization with Electrosurgery diffferent power settings

Interventions

Conization with Electrosurgery diffferent power settingsPROCEDURE

50 watts pure cut,50 watts blend mode

BlendHybridPure Cut

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication for LLETZ based on abnormal cervical cytology and/or biopsy
  • Ability to provide written informed consent -

You may not qualify if:

  • Pregnancy
  • Active cervical infection
  • History of cervical cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adana City Training and Research Hospital

Adana, 01060, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Prendiville W, Cullimore J, Norman S. Large loop excision of the transformation zone (LLETZ). A new method of management for women with cervical intraepithelial neoplasia. Br J Obstet Gynaecol. 1989 Sep;96(9):1054-60. doi: 10.1111/j.1471-0528.1989.tb03380.x.

    PMID: 2804007BACKGROUND

  • Watanabe Y, Fuchshuber P, Homma T, Bilgic E, Madani A, Hiki N, Cammack I, Noji T, Kurashima Y, Shichinohe T, Hirano S. An Unmodulated Very-Low-Voltage Electrosurgical Technology Creates Predictable and Ultimate Tissue Coagulation: From Experimental Data to Clinical Use. Surg Innov. 2020 Oct;27(5):492-498. doi: 10.1177/1553350620904610. Epub 2020 Mar 18.

    PMID: 32186463BACKGROUND

  • Nagar HA, Dobbs SP, McClelland HR, Price JH, McClean G, McCluggage WG. The large loop excision of the transformation zone cut or blend thermal artefact study: a randomized controlled trial. Int J Gynecol Cancer. 2004 Nov-Dec;14(6):1108-11. doi: 10.1111/j.1048-891X.2004.14608.x.

    PMID: 15571616BACKGROUND

MeSH Terms

Conditions

Uterine Cervical NeoplasmsUterine Cervical Dysplasia

Interventions

Conization

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPrecancerous Conditions

Intervention Hierarchy (Ancestors)

BiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Sevda Bas

    Universty of Health Science

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sevda Bas

CONTACT

05300327726drsevdabas@gmail.com

Asena Torun

CONTACT

05324347091B.Asena.Torun@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 28, 2026

Study Start

February 23, 2026

Primary Completion

April 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)