Sterilization, TubalRRSNCT02165709
Cohort Study of Risk Reducing Salpingectomy
A study testing Salpingectomy and Traditional sterilization in people with Sterilization, Tubal and Salpingectomy, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Women undergoing surgical sterilization will be interested in risk reducing salpingectomy, and surgeons performing the procedure will be able to successfully complete the salpingectomy. 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
- Sterilization, Tubal, Salpingectomy, Ovary
- What is being tested?
- Salpingectomy and Traditional sterilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Sep 2015
- 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 35 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women > 35 years requesting sterilization as interval procedure OR at time of cesarean delivery
- At least one living child
- English or Spanish speaking
- Sterilization planned as interval (laparoscopic) procedure via Family Planning Clinic services or at time of delivery
- Delivery by cesarean section (planned or following labor)
Who cannot join
- Age < 30
- Medical complications that increase risk for surgical bleeding (e.g. Idiopathic thrombocytopenic purpura (ITP); von Willebrand disease (vWD); need for prophylactic or therapeutic anticoagulation)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Hosptials
Chapel Hill, North Carolina, 27599
About this study
Official title: Cohort Study of Risk Reducing Salpingectomy (RRS) Versus Standard Tubal Sterilization Among Women Who Desire Sterilization
Women undergoing surgical sterilization will be interested in risk reducing salpingectomy, and surgeons performing the procedure will be able to successfully complete the salpingectomy.
- Conditions
- Sterilization, Tubal, Salpingectomy, Ovary, Prevention & Control
- Being tested
- Salpingectomy, Traditional sterilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalpingectomyProcedure or surgery
Traditional sterilizationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Salpingectomy | Experimental | Participants will be offered a risk-reducing salpingectomy, and if they choose this options the surgeon will proceed with a salpingectomy. Receives: Procedure: Salpingectomy |
| Traditional sterilization | Active comparator | Participants will be offered a risk-reducing salpingectomy, and those that choose a traditional sterilization will be in this treatment arm. Receives: Procedure: Traditional sterilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of women accepting RRS
Determination of patient demand/interest in pursuing RRS for sterilization during 12-month study period
Measured: 12 months
Secondary outcomes (1)
Percent of women with successful RRS completion
Feasibility will be defined as number (%) of successful RRS completion when intended
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sterilization, TubalStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Sponsor
- Investigators
- Matthew L Zerden, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165709
- Sponsor's protocol ID
- 14-0337
- Acronym
- RRS
- Status last verified
- Apr 2017
- First submitted
- 13 Jun 2014
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Risk Reducing Salpingectomy (RRS) Versus Standard Tubal Sterilization Among Women Who Desire Sterilization
- ClinicalTrials.gov ID
- NCT02165709
- Acronym / sponsor ID
- RRS / 14-0337
- Conditions
- Sterilization, Tubal, Salpingectomy, Ovary, Prevention & Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- Jun 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 17 Jun 2014 (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.
Women undergoing surgical sterilization will be interested in risk reducing salpingectomy, and surgeons performing the procedure will be able to successfully complete the salpingectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salpingectomy | Experimental | Procedure: SalpingectomyParticipants will be offered a risk-reducing salpingectomy, and if they choose this options the surgeon will proceed with a salpingectomy. |
| Traditional sterilization | Active comparator | Procedure: Traditional sterilizationParticipants will be offered a risk-reducing salpingectomy, and those that choose a traditional sterilization will be in this treatment arm. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women > 35 years requesting sterilization as interval procedure OR at time of cesarean delivery
- At least one living child
- English or Spanish speaking
- Sterilization planned as interval (laparoscopic) procedure via Family Planning Clinic services or at time of delivery
- Delivery by cesarean section (planned or following labor)
Key exclusion criteria (2 listed)
- Age < 30
- Medical complications that increase risk for surgical bleeding (e.g. Idiopathic thrombocytopenic purpura (ITP); von Willebrand disease (vWD); need for prophylactic or therapeutic anticoagulation)
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 |
|---|---|---|
| Salpingectomy | Procedure or surgery | Salpingectomy |
| Traditional sterilization | Procedure or surgery | Traditional sterilization |
Primary outcome
Percent of women accepting RRS
Time frame: 12 months
Determination of patient demand/interest in pursuing RRS for sterilization during 12-month study period
1 secondary outcome
Percent of women with successful RRS completion
Time frame: 12 months
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 25 Apr 2017.
Related trials for Sterilization, Tubal
Recruiting
Patient-centered Information on Permanent Contraception
Contraception, Reproductive Behavior
Recruiting
Assessment of Tubal Occlusion During Minimally Invasive Myomectomy
Fallopian Tube Patency Tests, Fibroid/Myoma (Uterus/Cervix)
Active, not recruiting
SALpingectomy for STERilization (SALSTER)
Sterilization Tubal, Salpingectomy
Enrolling by invitationObservational study
Stop Ovarian Cancer Young; Effect of the Opportunistic Salpingectomy on Age of Menopause
Salpingectomy, Tubal Ligation
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.
Matthew L Zerden, MD, MPH principal investigator
University of North Carolina, Chapel Hill
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 and Traditional sterilization in people with Sterilization, Tubal and Salpingectomy, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 5 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 25 Apr 2017. 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 United States. 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?
Percent of women accepting RRS (time frame: 12 months). 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 25 Apr 2017.