Tissue Sparing Therapy of Female Precancerous Genital Lesions With VITOM

NCT ID: NCT01601769

Last Updated: 2012-05-18

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-07-31

Brief Summary

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Object of the study is the evaluation of the use of a rigid laparoscope for the diagnosis and therapy of lesions of the female genital tract as a substitution or a complementary method to colposcopy with the development of new standards for a tissue sparing therapy Use of existing laparoscopic instruments, which allow a better quality level in the diagnosis and therapy than the current routine.

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

Detailed Description

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Conditions

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Cervical Preinvasive Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Colposcopy

a Carl Zeiss colposcope with a magnification power from 4x to 20x, with green filter.

Group Type ACTIVE_COMPARATOR

Colposcopy

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

Vitom

Intervention Type DEVICE

Patients treated and diagnosed by vitom

Interventions

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Vitom

Patients treated and diagnosed by vitom

Intervention Type DEVICE

Colposcopy

a Carl Zeiss colposcope with a magnification power from 4x to 20x, with green filter.

Patients treated by colposcopy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Karnowsky-Index \> 80,
* 18-80 years,
* CIN.

Exclusion Criteria

* Pregnancy,
* Previous or current cancer,
* Radio therapy of the pelvis,
* Serious internistic accompanying diseases,
* Psychiatric diseases,
* HIV infection,
* Drug addiction.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Giuseppe Vercellino

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Germany

Other Identifiers

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ENDOCOLP

Identifier Type: -

Identifier Source: org_study_id

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