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Fischer Cone Biopsy Excisor Versus Loop Excision Procedure for Conization

NCT02515162 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2016-08-16

No results posted yet for this study

Summary

In a randomized clinical trial of 160 women undergoing conization for cervical dysplasia, two electrosurgical excision methods, Fischer Cone Biopsy Excison vs. Loop Excision Procedure, will be compared. The primary outcome of the study is dysplasia-free resection margin rate, secondary outcomes are intraoperative blood loss, time to complete hemostasis, intervention time, postoperative pain, intra- and postoperative complications, the resected cone volume and users satisfaction.

Conditions

  • Uterine Cervical Dysplasia

Interventions

PROCEDURE

Fischer Cone Biopsy Excisor

Electrosurgical excision method using a triangular electrode to remove the abnormal cervical Transformation zone

PROCEDURE

Loop Excision Procedure

Electrosurgical excision method using a circular electrode to remove the abnormal cervical Transformation zone

Sponsors & Collaborators

  • Ruhr University of Bochum

    collaborator OTHER

  • Zydolab - Institute of Cytology and Immune Cytochemistry

    lead OTHER

Principal Investigators

  • Ziad Hilal, Dr. med. · Zydolab - Institute of Cytology and Immune Cytochemistry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-07-31
Completion
2016-08-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02515162 on ClinicalTrials.gov