This trial is active, not recruiting.

Condition cervical preinvasive disease
Treatments vitom, colposcopy
Sponsor Charite University, Berlin, Germany
Start date April 2011
End date July 2012
Trial size 300 participants
Trial identifier NCT01601769, ENDOCOLP


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
a Carl Zeiss colposcope with a magnification power from 4x to 20x, with green filter.
a Carl Zeiss colposcope with a magnification power from 4x to 20x, with green filter. Patients treated by colposcopy
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.
Patients treated and diagnosed by vitom

Primary Outcomes

Cervical volume removed
time frame: İmmediately after surgery
İntraoperative Complications
time frame: During the intraoperative
Short term complications
time frame: Within 48 hours after operation
Late complications
time frame: After 48 hours

Eligibility Criteria

Female participants of any age.

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.

Additional Information

Official title Development of a Tissue Sparing Procedure for the Diagnosis and Therapy of Female Precancerous Genital Lesions Combining Endoscopic and Ultrasound Technics.
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by Charite University, Berlin, Germany.