Tissue Sparing Therapy of Female Precancerous Genital Lesions With VITOM

NCT01601769 | Unknown

• 1 other identifier: ENDOCOLP
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Cervical Preinvasive Disease

Keywords

Cervical preinvasive disease; Colposcopy; Exocolposcopy; Leep

Outcome Measures

Primary Outcomes (4)

• Cervical volume removed

  Cervical volume removed during the operation is recorded

  İmmediately after surgery

• İntraoperative Complications

  Complications encountered during the prodecure

  During the intraoperative

• Short term complications

  Complications within 48 hours after operation

  Within 48 hours after operation

• Late complications

  Complications occuring after 48 hours

  After 48 hours

Study Arms (2)

Colposcopy

ACTIVE COMPARATOR

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

Device: Colposcopy

Vitom

EXPERIMENTAL

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.

Device: Vitom

Interventions

Vitom DEVICE

Patients treated and diagnosed by vitom

Vitom

Colposcopy DEVICE

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

Colposcopy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Karnowsky-Index \> 80,
• years,
• CIN.

You may not qualify if:

• Pregnancy,
• Previous or current cancer,
• Radio therapy of the pelvis,
• Serious internistic accompanying diseases,
• Psychiatric diseases,
• HIV infection,
• Drug addiction.

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité University Hospital

Berlin, State of Berlin, 12200, Germany

Location

MeSH Terms

Interventions

Colposcopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Achim Schneider, MD, MPH

  Charité University Hospital, Berlin, Germany

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 14, 2012
• First Posted: May 18, 2012
• Study Start: April 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: May 18, 2012

Record last verified: 2012-05

Locations

DE (1)