Tissue Sparing Therapy of Female Precancerous Genital Lesions With VITOM
This trial is active, not recruiting.
|Condition||cervical preinvasive disease|
|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
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Cervical volume removed
time frame: İmmediately after surgery
time frame: During the intraoperative
Short term complications
time frame: Within 48 hours after operation
time frame: After 48 hours
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.
|Official title||Development of a Tissue Sparing Procedure for the Diagnosis and Therapy of Female Precancerous Genital Lesions Combining Endoscopic and Ultrasound Technics.|
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