Tissue Sparing Therapy of Female Precancerous Genital Lesions With VITOM
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Purpose
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
| Condition | Intervention |
|---|---|
|
Cervical Preinvasive Disease |
Device: Vitom Device: Colposcopy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Development of a Tissue Sparing Procedure for the Diagnosis and Therapy of Female Precancerous Genital Lesions Combining Endoscopic and Ultrasound Technics. |
- Cervical volume removed [ Time Frame: İmmediately after surgery ] [ Designated as safety issue: No ]Cervical volume removed during the operation is recorded
- İntraoperative Complications [ Time Frame: During the intraoperative ] [ Designated as safety issue: Yes ]Complications encountered during the prodecure
- Short term complications [ Time Frame: Within 48 hours after operation ] [ Designated as safety issue: Yes ]Complications within 48 hours after operation
- Late complications [ Time Frame: After 48 hours ] [ Designated as safety issue: Yes ]Complications occuring after 48 hours
| Estimated Enrollment: | 300 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Colposcopy
a Carl Zeiss colposcope with a magnification power from 4x to 20x, with green filter.
|
Device: Colposcopy
a Carl Zeiss colposcope with a magnification power from 4x to 20x, with green filter. Patients treated by colposcopy |
|
Experimental: Vitom
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
Patients treated and diagnosed by vitom
|
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Germany | |
| Charité University Hospital | |
| Berlin, Germany, 12200 | |
| Study Director: | Achim Schneider, MD, MPH | Charité University Hospital Berlin, Germany |
More Information
No publications provided
| Responsible Party: | Giuseppe Vercellino, MD, Charite University, Berlin, Germany |
| ClinicalTrials.gov Identifier: | NCT01601769 History of Changes |
| Other Study ID Numbers: | ENDOCOLP |
| Study First Received: | May 14, 2012 |
| Last Updated: | May 16, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Charite University, Berlin, Germany:
|
Cervical preinvasive disease Colposcopy Exocolposcopy Leep |
ClinicalTrials.gov processed this record on June 18, 2013