NCT01894971

Brief 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. The pathologist evaluate the amount of fallopian tube tissue left at both cornual portion of cut off specimen.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

Enrollment Period

2.1 years

First QC Date

June 25, 2013

Last Update Submit

April 9, 2015

Conditions

RecruitingCompleted

Outcome Measures

Primary Outcomes (1)

  • Remnant fallopian tube tissue after coagulation wiht Ligasure®

    1 day

Study Arms (1)

twice coagulated side of fallopian tube

EXPERIMENTAL

twice coagulated side of fallopian tube once coagulated sied of fallopian tube

Device: The Effect of Ligasure® to Destroy Cornual Portion of Fallopian Tube

Interventions

The Effect of Ligasure® to Destroy Cornual Portion of Fallopian TubeDEVICE
twice coagulated side of fallopian tube

Eligibility Criteria

Age35 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • female 35-50
  • premenopausal
  • plan to perform hysterectomy

You may not qualify if:

  • disease in fallopian tube before surgery
  • has history of pelvic inflammatory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (1)

  • Unable to connect to PubMed to validate , last attempt on June 25, 2013 at 11:11 AM EDT

    BACKGROUND

Study Officials

  • Tae Joong Kim, MD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 25, 2013

First Posted

July 10, 2013

Study Start

November 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 10, 2015

Record last verified: 2015-04

Locations

KR(1)