Tissue Sparing Therapy of Female Precancerous Genital Lesions With VITOM

Charité University Medicine Berlin

Status: Unknown

Conditions: Cervical Preinvasive Disease

Treatments: Device: Vitom; Device: Colposcopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01601769

ENDOCOLP

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Colposcopy

Active Comparator group

Description:

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

Treatment:

Device: Colposcopy

Vitom

Experimental group

Description:

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.

Treatment:

Device: Vitom