Tissue Sparing Therapy of Female Precancerous Genital Lesions With VITOM

Cervical Preinvasive Disease Clinical Trial

— VITOM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01601769
• Other study ID #: ENDOCOLP
• Status: Active, not recruiting
• Phase: N/A
• First received: May 14, 2012
• Last updated: May 16, 2012
• Start date: April 2011
• Est. completion date: July 2012

Study information

• Verified date: May 2012
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Preinvasive Disease

Intervention

Device:
• Vitom
Patients treated and diagnosed by vitom
• Colposcopy
a Carl Zeiss colposcope with a magnification power from 4x to 20x, with green filter. Patients treated by colposcopy

Locations

Country	Name	City	State
Germany	Charité University Hospital	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cervical volume removed	Cervical volume removed during the operation is recorded	Immediately after surgery	No
Primary	Intraoperative Complications	Complications encountered during the prodecure	During the intraoperative	Yes
Primary	Short term complications	Complications within 48 hours after operation	Within 48 hours after operation	Yes
Primary	Late complications	Complications occuring after 48 hours	After 48 hours	Yes