Tissue Sparing Therapy of Female Precancerous Genital Lesions With VITOM

Development of a Tissue Sparing Procedure for the Diagnosis and Therapy of Female Precancerous Genital Lesions Combining Endoscopic and Ultrasound Technics.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01601769

Acronym

VITOM

Enrollment

300

Registered

2012-05-18

Start date

2011-04-30

Completion date

2012-07-31

Last updated

2012-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Preinvasive Disease

Keywords

Cervical preinvasive disease, Colposcopy, Exocolposcopy, Leep

Brief summary

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

Interventions

DEVICEVitom

Patients treated and diagnosed by vitom

DEVICEColposcopy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

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.

Design outcomes

Primary

Measure	Time frame	Description
Cervical volume removed	İmmediately after surgery	Cervical volume removed during the operation is recorded
İntraoperative Complications	During the intraoperative	Complications encountered during the prodecure
Short term complications	Within 48 hours after operation	Complications within 48 hours after operation
Late complications	After 48 hours	Complications occuring after 48 hours

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026