Cohort Study of Risk Reducing Salpingectomy | NCT02165709

Studies
Cohort Study of Risk Reducing Salpingectomy

NCT02165709

Sponsor

University of North Carolina, Chapel Hill

Status

Completed

Last Update Posted

Apr 25, 2017Actual

Enrollment

18Actual

Phase

Not Applicable

Conditions

Sterilization, Tubal
Salpingectomy
Ovary
Prevention & Control

Interventions

Salpingectomy
Traditional sterilization

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Aug 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Jun 13, 2014

First Submission Date that Met QC Criteria

Jun 13, 2014

First Posted Date

Jun 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2017

Last Update Posted Date

Apr 25, 2017Actual

Name	Class
Medtronic - MITG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Salpingectomy	Experimental	Participants will be offered a risk-reducing salpingectomy, and if they choose this options the surgeon will proceed with a salpingectomy.	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.	Procedure: Traditional sterilization

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Salpingectomy	Procedure		Salpingectomy
Traditional sterilization

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent of women accepting RRS	Determination of patient demand/interest in pursuing RRS for sterilization during 12-month study period	12 months

Secondary Outcomes

Measure	Description	Time Frame
Percent of women with successful RRS completion	Feasibility will be defined as number (%) of successful RRS completion when intended	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthew L Zerden, MD, MPH	University of North Carolina, Chapel Hill	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of North Carolina Hosptials		Chapel Hill	North Carolina	27599	United States

Intervention Browse Module

MeSH Terms

ID	Term
D058994	Salpingectomy

Ancestor Terms

ID	Term
D013509	Gynecologic Surgical Procedures
D013519	Urogenital Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided