Uterine FibroidNCT04191603
TWO DİFFERENT ELECTROSURGERY DEVICES AS MONOPOLAR HOOC AND PLASMAKINETIC BIPOLAR SPATULA EFFECTIVENESS DURING COLPOTOMY
A study testing MONOPOLAR HOOC and PLASMAKINETIC BIPOLAR SPATULA in people with Uterine Fibroid and Ovary Cyst, run by Alkü Alanya Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
WE DECIDED TO COMPARE TWO DIFFERENT ELECTROSURGERY DEVİCES TO PROVIDE COLPOTOMY. ONE OF THEM İS MONOPOLAR HOOC, THE OTHER DEVİCE İS PLASMAKİNETİC BİPOLAR SPATULA. WE WİLL RANDOMİSE PATİENTS FİRSTLY THEN COMPARE THE RESULTS SUCH, VAGİNAL DEHİSSENS, COLPOTOMY DURATİON, AMOUNT OF MIST DURING COLPOTOMY, AMOUNT OF BLEEDİNG. Read more about this study
- Who is it for?
- Ages 30 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Fibroid, Ovary Cyst, Endometrial Hyperplasia
- What is being tested?
- MONOPOLAR HOOC and PLASMAKINETIC BIPOLAR SPATULA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2020to 30 Dec 2021
- 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 30 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- APPROPIATE FOR TOTAL LAPAROSCOPIC HYSTERECTOMY
Who cannot join
- MALIGNANCY
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Alku Alanya Education and Research Hospital
Antalya
MERAL TUĞBA ÇİMŞİR, 05064742272, DR.TUGBAACAR@GMAİL.COM
About this study
Official title: THE EFFECTIVENESS OF MONOPOLAR HOOC VERSUS PLASMAKINETIC BİPOLAR SPATULA USAGE DURING COLPOTOMY PROCESS IN PATIENTS UNDERGOİNG TOTAL LAPAROSCOPIC HYSTERECTOMY
WE DECIDED TO COMPARE TWO DIFFERENT ELECTROSURGERY DEVİCES TO PROVIDE COLPOTOMY. ONE OF THEM İS MONOPOLAR HOOC, THE OTHER DEVİCE İS PLASMAKİNETİC BİPOLAR SPATULA. WE WİLL RANDOMİSE PATİENTS FİRSTLY THEN COMPARE THE RESULTS SUCH, VAGİNAL DEHİSSENS, COLPOTOMY DURATİON, AMOUNT OF MIST DURING COLPOTOMY, AMOUNT OF BLEEDİNG.
Read the detailed description
COLPOTOMY IS A PROCESS DURING TOTAL LAPAROSCOPIC HYSTERECTOMY. WE CAN USE EİTHER ELECTROSURGERY INSTRUMENTS TO PROVIDE COLPOTOMY. IN OUR TRIAL WE WİLL RANDOMİSE PATİENTS FİRSTLY THEN COMPARE THE RESULTS SUCH, VAGİNAL DEHİSSENS, COLPOTOMY DURATİON, AMOUNT OF MIST DURING COLPOTOMY, AMOUNT OF BLEEDİNG.
- Being tested
- MONOPOLAR HOOC, PLASMAKINETIC BIPOLAR SPATULA
- Medical subject headings
- Leiomyoma, Ovarian Cysts, Endometrial Hyperplasia, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MONOPOLAR HOOCDevice
COLPOTOMY WITH MONOPOLAR HOOC
PLASMAKINETIC BIPOLAR SPATULADevice
COLPOTOMY WITH BIPOLAR SPATULA
| Study group | Role | What they receive |
|---|---|---|
| MONOPOLAR HOOC | Active comparator | COLPOTOMY WITH USAGE MONOPOLAR HOOC Receives: Device: MONOPOLAR HOOC |
| PLASMAKINETIK BIPOLAR SPATULA | Active comparator | COLPOTOMY WITH USAGE MONOPOLAR HOOC Receives: Device: PLASMAKINETIC BIPOLAR SPATULA |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAGINAL DEHISSENS
AFTER LAPAROSCOPIC HYSTERECTOMY TWO DIFFERENT ELECTROSURGERY DEVICES RESULTS
Measured: 0 DAY-365 DAYS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start30 Oct 2020 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- MONOPOLAR HOOC VERSUS PLASMAKINETIC BIPOLAR SPATULA USAGE DURING COLPOTOMY
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alkü Alanya Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MERAL TUĞBA ÇİMŞİR, Alkü Alanya Education and Research Hospital
- Investigators
- MERAL TUĞBA ÇİMŞİR, Principal investigator, ALKU EDUCATİON AND RESEARCH HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191603
- Sponsor's protocol ID
- ALKU ERH
- Status last verified
- Jun 2020
- First submitted
- 4 Dec 2019
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 5 YEARS
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECTIVENESS OF MONOPOLAR HOOC VERSUS PLASMAKINETIC BİPOLAR SPATULA USAGE DURING COLPOTOMY PROCESS IN PATIENTS UNDERGOİNG TOTAL LAPAROSCOPIC HYSTERECTOMY
- ClinicalTrials.gov ID
- NCT04191603
- Acronym / sponsor ID
- ALKU ERH
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Alkü Alanya Education and Research HospitalUniversity, hospital or other
- Study start
- 30 Oct 2020 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 10 Dec 2019 (actual)
- 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.
WE DECIDED TO COMPARE TWO DIFFERENT ELECTROSURGERY DEVİCES TO PROVIDE COLPOTOMY. ONE OF THEM İS MONOPOLAR HOOC, THE OTHER DEVİCE İS PLASMAKİNETİC BİPOLAR SPATULA. WE WİLL RANDOMİSE PATİENTS FİRSTLY THEN COMPARE THE RESULTS SUCH, VAGİNAL DEHİSSENS, COLPOTOMY DURATİON, AMOUNT OF MIST DURING COLPOTOMY, AMOUNT OF BLEEDİNG.
Detailed description
COLPOTOMY IS A PROCESS DURING TOTAL LAPAROSCOPIC HYSTERECTOMY. WE CAN USE EİTHER ELECTROSURGERY INSTRUMENTS TO PROVIDE COLPOTOMY. IN OUR TRIAL WE WİLL RANDOMİSE PATİENTS FİRSTLY THEN COMPARE THE RESULTS SUCH, VAGİNAL DEHİSSENS, COLPOTOMY DURATİON, AMOUNT OF MIST DURING COLPOTOMY, AMOUNT OF BLEEDİNG.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- MONOPOLAR HOOC VERSUS PLASMAKINETIC BIPOLAR SPATULA USAGE DURING COLPOTOMY
| Arm | Type | Receives |
|---|---|---|
| MONOPOLAR HOOC | Active comparator | Device: MONOPOLAR HOOCCOLPOTOMY WITH USAGE MONOPOLAR HOOC |
| PLASMAKINETIK BIPOLAR SPATULA | Active comparator | Device: PLASMAKINETIC BIPOLAR SPATULACOLPOTOMY WITH USAGE MONOPOLAR HOOC |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- APPROPIATE FOR TOTAL LAPAROSCOPIC HYSTERECTOMY
Key exclusion criteria (1 listed)
- MALIGNANCY
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 |
|---|---|---|
| MONOPOLAR HOOCCOLPOTOMY WITH MONOPOLAR HOOC | Device | MONOPOLAR HOOC |
| PLASMAKINETIC BIPOLAR SPATULACOLPOTOMY WITH BIPOLAR SPATULA | Device | PLASMAKINETIK BIPOLAR SPATULA |
Primary outcome
VAGINAL DEHISSENS
Time frame: 0 DAY-365 DAYS
AFTER LAPAROSCOPIC HYSTERECTOMY TWO DIFFERENT ELECTROSURGERY DEVICES RESULTS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- Individual participant dataSharing planned: Yes. 5 YEARS
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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.
MERAL TUĞBA ÇİMŞİR principal investigator
ALKU EDUCATİON AND RESEARCH HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MONOPOLAR HOOC and PLASMAKINETIC BIPOLAR SPATULA in people with Uterine Fibroid and Ovary Cyst, run by Alkü Alanya Education and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 23 Jun 2020. 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 Turkey (Türkiye). 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?
Contact MERAL TUĞBA ÇİMŞİR (05064742272, dr.tugbaacar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAGINAL DEHISSENS (time frame: 0 DAY-365 DAYS). 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 23 Jun 2020.