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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05629611




Registration number
NCT05629611
Ethics application status
Date submitted
31/10/2022
Date registered
29/11/2022

Titles & IDs
Public title
Efficacy and Safety Evaluation of Vi-sealer
Scientific title
Efficacy and Safety Evaluation of Advanced Vessel Sealing Device (Vi-sealer)
Secondary ID [1] 0 0
KGOG4009_Vi-TLH
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Gynecologic Neoplasm 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Vi-Sealer
Treatment: Devices - Ligasure
Treatment: Devices - Other AHD

Experimental: Study 1 Vi-Sealer - This group of women undergoing hysterectomy is randomized to the energy device, Vi-sealer.

Active comparator: Study 1 Ligasure - This group of women undergoing hysterectomy is randomized to the energy device, Ligasure.

Experimental: Study 2 Vi-sealer - This group of women undergoing hysterectomy is randomized to the energy device, Vi-sealer.

Active comparator: Study 2 Other AHD - This group of women undergoing hysterectomy is randomized to energy devices other than Ligasure.


Treatment: Devices: Vi-Sealer
using Reusable device, Vi-Sealer

Treatment: Devices: Ligasure
using Ligasure

Treatment: Devices: Other AHD
Using other AHDs such as Thunderbeat, Harmonic scalpel, Caiman®, Enseal, etc. except Ligasure
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Operative procedure time
Timepoint [1] 0 0
through study completion, an average of 1 year
Primary outcome [2] 0 0
Estimated blood loss
Timepoint [2] 0 0
through study completion, an average of 1 year
Secondary outcome [1] 0 0
Estimated medical cost of device
Timepoint [1] 0 0
within 6 weeks after intervention
Secondary outcome [2] 0 0
Device evaluation score
Timepoint [2] 0 0
through study completion, an average of 1 year
Secondary outcome [3] 0 0
Adverse events
Timepoint [3] 0 0
within 6 weeks after intervention

Eligibility
Key inclusion criteria
1. Aged 20 to 65 years
2. Clinically diagnosed with benign gynecologic neoplasms (eg. adenomyosis, uterine fibroids, etc.)
3. Eligible for hysterectomy
4. Signing an written consent form indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study prior to any other study-related assessments or procedure
Minimum age
20 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Large uterus size over 16 weeks of gestational age
2. Cervical or intraligamentary fibroids
3. Severe endometriosis (stage 3 or 4)
4. Suspected malignancy of the uterus or adnexa
5. Contraindicated for the use of energy devices (such as implantable cardioverter defibrillators, pacemakers)
6. Previous pelvic surgery = 3 times
7. Not suitable for laparoscopic surgery

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Korea, Republic of
State/province [1] 0 0
Gyeonggi-do

Funding & Sponsors
Primary sponsor type
Other
Name
Hyun Park
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Hyun Park
Address 0 0
Country 0 0
Phone 0 0
+82-031-780-5640
Fax 0 0
Email 0 0
p06162006@cha.ac.kr
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05629611