CClinicalTrials.gg
CompletedNCT01894971Updated Apr 10, 2015

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

A Phase 3 interventional study of The Effect of Ligasure® to Destroy Cornual Portion of Fallopian Tube in Recruiting and Completed, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to female participants aged 35 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-10.

Sponsored by Samsung Medical Center · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
35 Years to 60 Years
Sex
Female
01

Study 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.

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®.

02

Conditions studied

  • Recruiting
  • Completed
03

In context

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • disease in fallopian tube before surgery
  • has history of pelvic inflammatory disease
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    twice coagulated side of fallopian tube

    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

  • DeviceThe Effect of Ligasure® to Destroy Cornual Portion of Fallopian Tube
06

What researchers measure

Primary outcomes

  1. Remnant fallopian tube tissue after coagulation wiht Ligasure®

    Time frame: 1 day

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, 135-710, Korea, Republic of
08

References and documents

Publications

  • Unable to connect to PubMed to validate , last attempt on June 25, 2013 at 11:11 AM EDT
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01894971
Lead sponsor
Samsung Medical Center
Responsible party
Tae-Joong Kim (Assistant Professor, Samsung Medical Center) — Principal investigator
First posted
Jul 10, 2013
Start date
Nov 2012
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Apr 10, 2015

Study contacts

Tae Joong Kim, MD
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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