Ovarian Cancer PreventionNCT06032962
Opportunistic Salpingectomy in Non-gynecological Surgeries
A study testing salpingectomy in people with Ovarian Cancer Prevention, run by Dana Josephy at 1 site in Israel.
Trial summary
The goal of this study is to evaluate patient's compliance for opportunistic salpingectomy (OS) and procedure feasibility in non gynecological abdominal surgeries Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Ovarian Cancer Prevention
- What is being tested?
- salpingectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2018to 28 Feb 2023
- 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who were candidates for non-gynecological abdominal surgery
- Aged 45 or older, or aged 40 or older with a desire for bilateral salpingectomy
Who cannot join
- Pregnant women
- Candidates for urgent surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Opportunistic Salpingectomy in Non-gynecological Surgeries - a Pilot Study
The goal of this study is to evaluate patient's compliance for opportunistic salpingectomy (OS) and procedure feasibility in non gynecological abdominal surgeries
Read the detailed description
Patients who are candidate for non-gynecological abdominal surgery, are offered OS. If agree, a general surgeon perform the procedure during the planned abdominal surgery
- Conditions
- Ovarian Cancer Prevention
- Being tested
- salpingectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salpingectomyProcedure or surgery
surgical removal of the fallopian tubes
| Study group | Role | What they receive |
|---|---|---|
| non-gynecologic surgery | Experimental | Female candidates for non-gynecologic abdominal surgery Receives: Procedure: salpingectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
patients willing for salpingectomy
The number of patients that will agree for salpingectomy
Measured: day of enrollment
patients undergoing salpingectomy
The number of patients that will undergo salpingectomy
Measured: from enrollment and up to 6 weeks
length of salpingectomy
the length (in minutes) of salpingectomy
Measured: within surgery
surgical complications
complications during or after salpingectomy
Measured: up to 30 days from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Jan 2018
- Primary completion31 Dec 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Cancer PreventionStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana Josephy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dana Josephy, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032962
- Sponsor's protocol ID
- MeirMedicalCenter
- Status last verified
- Sep 2023
- First submitted
- 19 Jul 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opportunistic Salpingectomy in Non-gynecological Surgeries - a Pilot Study
- ClinicalTrials.gov ID
- NCT06032962
- Acronym / sponsor ID
- MeirMedicalCenter
- Conditions
- Ovarian Cancer Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Dana JosephyUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 13 Sep 2023 (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.
The goal of this study is to evaluate patient's compliance for opportunistic salpingectomy (OS) and procedure feasibility in non gynecological abdominal surgeries
Detailed description
Patients who are candidate for non-gynecological abdominal surgery, are offered OS. If agree, a general surgeon perform the procedure during the planned abdominal surgery
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non-gynecologic surgery | Experimental | Procedure: salpingectomyFemale candidates for non-gynecologic abdominal surgery |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women who were candidates for non-gynecological abdominal surgery
- Aged 45 or older, or aged 40 or older with a desire for bilateral salpingectomy
Key exclusion criteria (2 listed)
- Pregnant women
- Candidates for urgent surgery
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 |
|---|---|---|
| salpingectomysurgical removal of the fallopian tubes | Procedure or surgery | non-gynecologic surgery |
Primary outcome
patients willing for salpingectomy
Time frame: day of enrollment
The number of patients that will agree for salpingectomy
patients undergoing salpingectomy
Time frame: from enrollment and up to 6 weeks
The number of patients that will undergo salpingectomy
length of salpingectomy
Time frame: within surgery
the length (in minutes) of salpingectomy
surgical complications
Time frame: up to 30 days from surgery
complications during or after salpingectomy
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 13 Sep 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing salpingectomy in people with Ovarian Cancer Prevention, run by Dana Josephy at 1 site in Israel.
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 2 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 13 Sep 2023. 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 Israel. 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?
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?
patients willing for salpingectomy (time frame: day of enrollment). 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 13 Sep 2023.