RecruitingPhase 3NCT01894971
The Effect of Ligasure® to Destroy Cornual Portion of Fallopian Tube
A Phase 3 study testing The Effect of Ligasure® to Destroy Cornual Portion of Fallopian Tube in people with Recruiting and Completed, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Single-center prospective randomized trial to evaluate the effect of thermal damage of Ligasure® to destroy cornual portion of fallopian tube tisse. Right of Left side of fallpian tube is randomized and coagulated one more time than other side before cut off. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recruiting, Completed
- What is being tested?
- The Effect of Ligasure® to Destroy Cornual Portion of Fallopian Tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2012to Dec 2014
- Phase
- Phase 3
- 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 35 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female 35-50
- premenopausal
- plan to perform hysterectomy
Who cannot join
- disease in fallopian tube before surgery
- has history of pelvic inflammatory disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Thermal Damage of Ligasure® to Destroy Cornual Portion of Fallopian Tube Tissue
Single-center prospective randomized trial to evaluate the effect of thermal damage of Ligasure® to destroy cornual portion of fallopian tube tisse.
Right of Left side of fallpian tube is randomized and coagulated one more time than other side before cut off. The pathologist evaluate the amount of fallopian tube tissue left at both cornual portion of cut off specimen.
Read the detailed description
When investigators perform salpingectomy, both side of cornual portion of the uterus are coagulated by Ligasure®. The randomized, the same word selected side of the fallopian tube is coagulated one more time at the cornual portion than unselected other side of fallopian tube. Hypothesis is that the side selected and coagulated twice would have less fallopian tube tisse left at fianl pathology than the side only once coagulated by Ligasure®.
- Conditions
- Recruiting, Completed
- Being tested
- The Effect of Ligasure® to Destroy Cornual Portion of Fallopian Tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Effect of Ligasure® to Destroy Cornual Portion of Fallopian TubeDevice
| Study group | Role | What they receive |
|---|---|---|
| twice coagulated side of fallopian tube | Experimental | twice coagulated side of fallopian tube once coagulated sied of fallopian tube Receives: Device: The Effect of Ligasure® to Destroy Cornual Portion of Fallopian Tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remnant fallopian tube tissue after coagulation wiht Ligasure®
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startNov 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RecruitingStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae-Joong Kim, Samsung Medical Center
- Investigators
- Tae Joong Kim, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894971
- Sponsor's protocol ID
- 2013-06-25
- Status last verified
- Apr 2015
- First submitted
- 25 Jun 2013
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Unable to connect to PubMed to validate , last attempt on June 25, 2013 at 11:11 AM EDT
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Thermal Damage of Ligasure® to Destroy Cornual Portion of Fallopian Tube Tissue
- ClinicalTrials.gov ID
- NCT01894971
- Acronym / sponsor ID
- 2013-06-25
- Conditions
- Recruiting, Completed
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Jul 2013 (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.
Single-center prospective randomized trial to evaluate the effect of thermal damage of Ligasure® to destroy cornual portion of fallopian tube tisse.
Right of Left side of fallpian tube is randomized and coagulated one more time than other side before cut off. The pathologist evaluate the amount of fallopian tube tissue left at both cornual portion of cut off specimen.
Detailed description
When investigators perform salpingectomy, both side of cornual portion of the uterus are coagulated by Ligasure®. The randomized, the same word selected side of the fallopian tube is coagulated one more time at the cornual portion than unselected other side of fallopian tube. Hypothesis is that the side selected and coagulated twice would have less fallopian tube tisse left at fianl pathology than the side only once coagulated by Ligasure®.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| twice coagulated side of fallopian tube | Experimental | Device: The Effect of Ligasure® to Destroy Cornual Portion of Fallopian Tubetwice coagulated side of fallopian tube once coagulated sied of fallopian tube |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- female 35-50
- premenopausal
- plan to perform hysterectomy
Key exclusion criteria (2 listed)
- disease in fallopian tube before surgery
- has history of pelvic inflammatory disease
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 |
|---|---|---|
| The Effect of Ligasure® to Destroy Cornual Portion of Fallopian Tube | Device | twice coagulated side of fallopian tube |
Primary outcome
Remnant fallopian tube tissue after coagulation wiht Ligasure®
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
- BackgroundUnable to connect to PubMed to validate , last attempt on June 25, 2013 at 11:11 AM EDT
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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.
Tae Joong Kim, MD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing The Effect of Ligasure® to Destroy Cornual Portion of Fallopian Tube in people with Recruiting and Completed, run by Samsung Medical Center at 1 site in South Korea.
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 2 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: finished, as of the sponsor's last update on 10 Apr 2015. 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 South Korea. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Remnant fallopian tube tissue after coagulation wiht Ligasure® (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01894971, which also lists 1 linked publication.
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 10 Apr 2015.