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Tissue Sparing Therapy of Female Precancerous Genital Lesions With VITOM (VITOM)

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ClinicalTrials.gov Identifier: NCT01601769
Recruitment Status : Unknown
Verified May 2012 by Giuseppe Vercellino, Charite University, Berlin, Germany.
Recruitment status was:  Active, not recruiting
First Posted : May 18, 2012
Last Update Posted : May 18, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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


Condition or disease Intervention/treatment
Cervical Preinvasive Disease Device: Vitom Device: Colposcopy

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development of a Tissue Sparing Procedure for the Diagnosis and Therapy of Female Precancerous Genital Lesions Combining Endoscopic and Ultrasound Technics.
Study Start Date : April 2011
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : July 2012
Arms and Interventions

Arm Intervention/treatment
Active Comparator: Colposcopy
a Carl Zeiss colposcope with a magnification power from 4x to 20x, with green filter.
Device: Colposcopy

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

Patients treated by colposcopy

Experimental: 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.
Device: Vitom
Patients treated and diagnosed by vitom


Outcome Measures

Primary Outcome Measures :
  1. Cervical volume removed [ Time Frame: İmmediately after surgery ]
    Cervical volume removed during the operation is recorded

  2. İntraoperative Complications [ Time Frame: During the intraoperative ]
    Complications encountered during the prodecure

  3. Short term complications [ Time Frame: Within 48 hours after operation ]
    Complications within 48 hours after operation

  4. Late complications [ Time Frame: After 48 hours ]
    Complications occuring after 48 hours


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01601769


Locations
Germany
Charité University Hospital
Berlin, Germany, 12200
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Study Director: Achim Schneider, MD, MPH Charité University Hospital Berlin, Germany
More Information

Responsible Party: Giuseppe Vercellino, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01601769     History of Changes
Other Study ID Numbers: ENDOCOLP
First Posted: May 18, 2012    Key Record Dates
Last Update Posted: May 18, 2012
Last Verified: May 2012

Keywords provided by Giuseppe Vercellino, Charite University, Berlin, Germany:
Cervical preinvasive disease
Colposcopy
Exocolposcopy
Leep