Cervical Preinvasive Disease Clinical Trial
Official title:
Development of a Tissue Sparing Procedure for the Diagnosis and Therapy of Female Precancerous Genital Lesions Combining Endoscopic and Ultrasound Technics.
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
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment