Cervix NeoplasmNCT07372248
Thermal Artifact in Patients Undergoing Conization: A Clinical Study
A study testing Conization with Electrosurgery diffferent power settings in people with Cervix Neoplasm and Cervix, Dysplasia, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Cervical transformation zone excision is commonly used in the diagnosis and treatment of cervical intraepithelial neoplasia. Thermal artifacts can negatively affect histopathological evaluation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervix Neoplasm, Cervix, Dysplasia
- What is being tested?
- Conization with Electrosurgery diffferent power settings
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Feb 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for LLETZ based on abnormal cervical cytology and/or biopsy
- Ability to provide written informed consent -
Who cannot join
- Pregnancy
- Active cervical infection
- History of cervical cancer
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Adana City Training and Research Hospital
Adana, 01060
Sevda Bas, 05300327726, drsevdabas@gmail.com
Mehtap Polat, Md, +5052603674, drmehtap0202@gmail.com
About this study
Official title: Comparison of the Effects of Different Surgical Techniques on the Degree of Thermal Artifact in Patients Undergoing Conization: A Clinical Study
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.
Read the detailed description
Conization procedures performed using electrosurgical techniques, such as LEEP, NETZ, and SWETZ, are well described in the literature. Compared with cold knife conization, these methods offer several advantages, including the ability to be performed under local anesthesia, shorter procedure time, and lower cost. However, electrosurgical techniques may compromise histopathological evaluation of surgical specimens due to the presence of thermal artifacts, which can obscure tissue architecture and surgical margins.
In our clinic, conization procedures are routinely performed using a hybrid technique that combines electrosurgery with cold knife conization. This study aims to compare three different modifications of this hybrid technique applied in our institution with respect to the degree of thermal artifact formation and the quality of surgical margin evaluation.
- Conditions
- Cervix Neoplasm, Cervix, Dysplasia
- Being tested
- Conization with Electrosurgery diffferent power settings
- Keywords
- conization
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conization with Electrosurgery diffferent power settingsProcedure or surgery
50 watts pure cut,50 watts blend mode
| Study group | Role | What they receive |
|---|---|---|
| Pure Cut | Active comparator | Conization with Electrosurgery: Power Setting 50 watts pure cut Receives: Procedure: Conization with Electrosurgery diffferent power settings |
| Blend | Active comparator | Conization with Electrosurgery:Power Setting 50 watts blend Receives: Procedure: Conization with Electrosurgery diffferent power settings |
| Hybrid | Experimental | Conization with Electrosurgery and Knife: Power Setting 50 watts pure cut and knife Receives: Procedure: Conization with Electrosurgery diffferent power settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 7 days following the surgical procedure
Secondary outcomes (1)
TZ evaluation
Transformation zone visibility will be evaluated during postoperative colposcopic examination and categorized as fully visible, partially visible, or not visible.
Measured: postoperative 4th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start23 Feb 2026
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cervix NeoplasmStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sevda Bas, Principal investigator, Universty of Health Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372248
- Sponsor's protocol ID
- 106751
- Status last verified
- Feb 2026
- First submitted
- 5 Jan 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 2804007Watanabe 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.
PubMed 32186463Nagar 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.
PubMed 15571616
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Different Surgical Techniques on the Degree of Thermal Artifact in Patients Undergoing Conization: A Clinical Study
- ClinicalTrials.gov ID
- NCT07372248
- Acronym / sponsor ID
- 106751
- Conditions
- Cervix Neoplasm, Cervix, Dysplasia
- Keywords
- conization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 28 Jan 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.
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.
Detailed description
Conization procedures performed using electrosurgical techniques, such as LEEP, NETZ, and SWETZ, are well described in the literature. Compared with cold knife conization, these methods offer several advantages, including the ability to be performed under local anesthesia, shorter procedure time, and lower cost. However, electrosurgical techniques may compromise histopathological evaluation of surgical specimens due to the presence of thermal artifacts, which can obscure tissue architecture and surgical margins.
In our clinic, conization procedures are routinely performed using a hybrid technique that combines electrosurgery with cold knife conization. This study aims to compare three different modifications of this hybrid technique applied in our institution with respect to the degree of thermal artifact formation and the quality of surgical margin evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pure Cut | Active comparator | Procedure: Conization with Electrosurgery diffferent power settingsConization with Electrosurgery: Power Setting 50 watts pure cut |
| Blend | Active comparator | Procedure: Conization with Electrosurgery diffferent power settingsConization with Electrosurgery:Power Setting 50 watts blend |
| Hybrid | Experimental | Procedure: Conization with Electrosurgery diffferent power settingsConization with Electrosurgery and Knife: Power Setting 50 watts pure cut and knife |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Indication for LLETZ based on abnormal cervical cytology and/or biopsy
- Ability to provide written informed consent -
Key exclusion criteria (4 listed)
- Pregnancy
- Active cervical infection
- History of cervical cancer
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conization with Electrosurgery diffferent power settings50 watts pure cut,50 watts blend mode | Procedure or surgery | Blend, Hybrid, Pure Cut |
Primary outcome
Thermal Artefact
Time frame: Within 7 days following the surgical procedure
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.
1 secondary outcome
TZ evaluation
Time frame: postoperative 4th month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Background: PubMed 2804007Prendiville 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.
- Background: PubMed 32186463Watanabe 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.
- Background: PubMed 15571616Nagar 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.
- 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.
Sevda Bas principal investigator
Universty of Health Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conization with Electrosurgery diffferent power settings in people with Cervix Neoplasm and Cervix, Dysplasia, run by Saglik Bilimleri Universitesi 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 2 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: looking for participants now, as of the sponsor's last update on 2 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sevda Bas (05300327726, drsevdabas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thermal Artefact (time frame: Within 7 days following the surgical procedure). 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 NCT07372248, which also lists 3 linked publications.
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 2 Mar 2026.