Cervical Preinvasive DiseaseVITOMNCT01601769
Tissue Sparing Therapy of Female Precancerous Genital Lesions With VITOM
A study testing Vitom and Colposcopy in people with Cervical Preinvasive Disease, run by Charite University, Berlin, Germany at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cervical Preinvasive Disease
- What is being tested?
- Vitom and Colposcopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2011to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Karnowsky-Index > 80,
- 18-80 years,
- CIN.
Who cannot join
- Pregnancy,
- Previous or current cancer,
- Radio therapy of the pelvis,
- Serious internistic accompanying diseases,
- Psychiatric diseases,
- HIV infection,
- Drug addiction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Tissue Sparing Procedure for the Diagnosis and Therapy of Female Precancerous Genital Lesions Combining Endoscopic and Ultrasound Technics.
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
- Being tested
- Vitom, Colposcopy
- Keywords
- Cervical preinvasive disease, Colposcopy, Exocolposcopy, Leep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitomDevice
Patients treated and diagnosed by vitom
ColposcopyDevice
a Carl Zeiss colposcope with a magnification power from 4x to 20x, with green filter.
Patients treated by colposcopy
| Study group | Role | What they receive |
|---|---|---|
| Colposcopy | Active comparator | a Carl Zeiss colposcope with a magnification power from 4x to 20x, with green filter. Receives: 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. Receives: Device: Vitom |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical volume removed
Cervical volume removed during the operation is recorded
Measured: İmmediately after surgery
İntraoperative Complications
Complications encountered during the prodecure
Measured: During the intraoperative
Short term complications
Complications within 48 hours after operation
Measured: Within 48 hours after operation
Late complications
Complications occuring after 48 hours
Measured: After 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startApr 2011
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Preinvasive DiseaseStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Vercellino, Charite University, Berlin, Germany
- Investigators
- Achim Schneider, MD, MPH, Study director, Charité University Hospital, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601769
- Sponsor's protocol ID
- ENDOCOLP
- Acronym
- VITOM
- Status last verified
- May 2012
- First submitted
- 14 May 2012
- Last updated
- 18 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Tissue Sparing Procedure for the Diagnosis and Therapy of Female Precancerous Genital Lesions Combining Endoscopic and Ultrasound Technics.
- ClinicalTrials.gov ID
- NCT01601769
- Acronym / sponsor ID
- VITOM / ENDOCOLP
- Conditions
- Cervical Preinvasive Disease
- Keywords
- Cervical preinvasive disease, Colposcopy, Exocolposcopy, Leep
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 18 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colposcopy | Active comparator | Device: Colposcopya Carl Zeiss colposcope with a magnification power from 4x to 20x, with green filter. |
| Vitom | Experimental | Device: VitomThe 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Karnowsky-Index > 80,
- 18-80 years,
- CIN.
Key exclusion criteria (7 listed)
- Pregnancy,
- Previous or current cancer,
- Radio therapy of the pelvis,
- Serious internistic accompanying diseases,
- Psychiatric diseases,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VitomPatients treated and diagnosed by vitom | Device | Vitom |
| Colposcopya Carl Zeiss colposcope with a magnification power from 4x to 20x, with green filter. Patients treated by colposcopy | Device | Colposcopy |
Primary outcome
Cervical volume removed
Time frame: İmmediately after surgery
Cervical volume removed during the operation is recorded
İntraoperative Complications
Time frame: During the intraoperative
Complications encountered during the prodecure
Short term complications
Time frame: Within 48 hours after operation
Complications within 48 hours after operation
Late complications
Time frame: After 48 hours
Complications occuring after 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Achim Schneider, MD, MPH study director
Charité University Hospital, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitom and Colposcopy in people with Cervical Preinvasive Disease, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical volume removed (time frame: İmmediately after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2012.