Tissue Sparing Therapy of Female Precancerous Genital Lesions With VITOM
NCT ID: NCT01601769
Last Updated: 2012-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2011-04-30
2012-07-31
Brief Summary
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Development of new optics and instruments, which allow a tissue sparing approach Pre and postoperative measurement of the cervical volume, to be sure that the tissue removal is kept to a minimum level Development of qualitaty parameters for the most tissue respecting operations of the uterine cervix Prospective evaluation of the influence of tissue sparing surgery on future pregnancies
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Colposcopy
a Carl Zeiss colposcope with a magnification power from 4x to 20x, with green filter.
Colposcopy
a Carl Zeiss colposcope with a magnification power from 4x to 20x, with green filter.
Patients treated by colposcopy
Vitom
The VITOM system, consisting of the VITOM scope, xenon light source, HD camera system, AIDA HD documentation system, 1 monitor, and a mechanical support arm (all Karl Storz, Tuttlingen, Germany) is used for video exocolposcopy.
Vitom
Patients treated and diagnosed by vitom
Interventions
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Vitom
Patients treated and diagnosed by vitom
Colposcopy
a Carl Zeiss colposcope with a magnification power from 4x to 20x, with green filter.
Patients treated by colposcopy
Eligibility Criteria
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Inclusion Criteria
* 18-80 years,
* CIN.
Exclusion Criteria
* Previous or current cancer,
* Radio therapy of the pelvis,
* Serious internistic accompanying diseases,
* Psychiatric diseases,
* HIV infection,
* Drug addiction.
FEMALE
No
Sponsors
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Charite University, Berlin, Germany
OTHER
Responsible Party
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Giuseppe Vercellino
MD
Principal Investigators
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Achim Schneider, MD, MPH
Role: STUDY_DIRECTOR
Charité University Hospital, Berlin, Germany
Locations
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Charité University Hospital
Berlin, State of Berlin, Germany
Countries
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Other Identifiers
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ENDOCOLP
Identifier Type: -
Identifier Source: org_study_id
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