Tissue Sparing Therapy of Female Precancerous Genital Lesions With VITOM

• Sponsor: Charite University, Berlin, Germany (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01601769
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arms: 2
• Duration (Months): 15
• Patients Per Site Per Month: 20

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Cervical Preinvasive Disease	Device: Vitom; Device: Colposcopy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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.
• Study Start Date: Apr 1, 2011
• Anticipated Primary Completion Date: Jul 1, 2012
• Anticipated Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Cervical volume removed [İmmediately after surgery]

   Cervical volume removed during the operation is recorded

2. İntraoperative Complications [During the intraoperative]

   Complications encountered during the prodecure

3. Short term complications [Within 48 hours after operation]

   Complications within 48 hours after operation

4. Late complications [After 48 hours]

   Complications occuring after 48 hours

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes 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

Locations

	Site	City	State	Country	Postal Code
1	Charité University Hospital	Berlin		Germany	12200

Sponsors and Collaborators

• Charite University, Berlin, Germany

Investigators

• Study Director: Achim Schneider, MD, MPH, Charité University Hospital Berlin, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Giuseppe Vercellino, MD, Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT01601769
• Other Study ID Numbers: ENDOCOLP
• First Posted: May 18, 2012
• Last Update Posted: May 18, 2012
• Last Verified: May 1, 2012

• Keywords provided by Giuseppe Vercellino, MD, Charite University, Berlin, Germany: Cervical preinvasive disease; Colposcopy; Exocolposcopy; Leep

Study Results

No Results Posted as of May 18, 2012