Tissue Sparing Therapy of Female Precancerous Genital Lesions With VITOM

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Charite University, Berlin, Germany.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Giuseppe Vercellino, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01601769
First received: May 14, 2012
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

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 Intervention
Cervical Preinvasive Disease
Device: Vitom
Device: Colposcopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Cervical volume removed [ Time Frame: İmmediately after surgery ] [ Designated as safety issue: No ]
    Cervical volume removed during the operation is recorded

  • İntraoperative Complications [ Time Frame: During the intraoperative ] [ Designated as safety issue: Yes ]
    Complications encountered during the prodecure

  • Short term complications [ Time Frame: Within 48 hours after operation ] [ Designated as safety issue: Yes ]
    Complications within 48 hours after operation

  • Late complications [ Time Frame: After 48 hours ] [ Designated as safety issue: Yes ]
    Complications occuring after 48 hours


Estimated Enrollment: 300
Study Start Date: April 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders 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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Giuseppe Vercellino, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01601769     History of Changes
Other Study ID Numbers: ENDOCOLP
Study First Received: May 14, 2012
Last Updated: May 16, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on September 14, 2014