Ovarian Cyst BenignPhase 3PRAHANCT03374397
PReservation Study of Ovarian Function And Hemostasis, and Its Safety of Surgiguard@ During Laparoscopic Ovarian Cystectomy
A Phase 3 study testing Surgiguard in people with Ovarian Cyst Benign, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to compare hemostasis, ovarian function preservation effect, and safety about intraoperative bleeding with SurgiGuard@ in women who underwent laparoscopic unilateral ovarian cystectomy Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Ovarian Cyst Benign
- What is being tested?
- Surgiguard
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Dec 2017to 31 Aug 2019
- Phase
- Phase 3
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female, 18 years ≤ Ages <45 years
- laparoscopic unilateral ovarian cystectomy scheduled patients with benign unilateral ovarian cyst confirmed by ultrasonography
- women with regular menstruation
- women with regular menstruation cycle from 21 days to 45 days
- Proper state for laparoscopic operation (American society of Anesthesiologists Physical Status classification 1 or 2)
- Patients who signed and approved informed consent
Who cannot join
- Patients without ovarian cyst
- Patients with malignant female genital disease
- Patients with bilateral ovarian cysts
- Age ≥ 45
- Pregnancy or lactating women
- Serum AMH<0.05 ng/ml
Show all 9Show fewer
- Patients with endocrine disease such as thyroid abnormality, hyperprolactinemia, cushing disease, etc
- Patients with hormone replacement therapy during 3 months
- Patients who is considered to be difficult to perform the clinical trial when researchers judge
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Randomized, Investigator-initiated Phase III Trial to Evaluate the Efficacy of Preservation of Ovarian Function and Hemostasis, and Its Safety of Surgiguard@ During Laparoscopic Ovarian Cystectomy
The purpose of this study is to compare hemostasis, ovarian function preservation effect, and safety about intraoperative bleeding with SurgiGuard@ in women who underwent laparoscopic unilateral ovarian cystectomy
Read the detailed description
In women who underwent laparoscopic unilateral ovarian cystectomy, the effect of SurgiGuard@ was assessed by randomization, using SurgiGuard@ and Bipolar electro cauterization, followed by comparative evaluation of hemostasis, ovarian function preservation, safety using postoperative Hb, anti-mullerian hormone (AMH), pelvis ultrasonography (USG), and physical examination
- Conditions
- Ovarian Cyst Benign
- Being tested
- Surgiguard
- Keywords
- Laparoscopic unilateral ovarian cystectomy, SurgiGuard, Hemostasis, Ovarian function preservation, Bipolar electrocauterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgiguardDrug
Also called laparoscopic unilateral ovarian cystectomy
Hemostasis with Surgiguard during laparoscopic unilateral ovarian cystectomy
| Study group | Role | What they receive |
|---|---|---|
| SurgiGuard | Active comparator | Surgiguard Non-woven Drug : SurgiGuard Non-woven 6g during surgery Receives: Drug: Surgiguard |
| Bipolar electrocauterization | No intervention | Bipolar electrocauterization during surgery Drug(-) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemostasis
Change of serum hemoglobin from baseline
Measured: post operative 48 hours later,1 week later, and 12 weeks later
Secondary outcomes (2)
Ovarian function preservation
Change of serum AMH from baseline
Measured: post operative 48 hours later,1 week later, and 12 weeks later
Volume of ovary
ovarian volume measured by ultrasonography
Measured: post operative 48 hours later,1 week later, and 12 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start6 Dec 2017
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian Cyst BenignStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee Seung Kim, Seoul National University Hospital
- Investigators
- Hee Seung Kim, MD/PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374397
- Sponsor's protocol ID
- 2017-1707
- Acronym
- PRAHA
- Status last verified
- Dec 2019
- First submitted
- 10 Dec 2017
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Park SJ, Seol A, Lee N, Lee S, Kim HS; PRAHA Study Group. A randomized controlled trial of ovarian reserve preservation and hemostasis during ovarian cystectomy. Sci Rep. 2021 Apr 19;11(1):8495. doi: 10.1038/s41598-021-87965-7.
PubMed 33875738
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Investigator-initiated Phase III Trial to Evaluate the Efficacy of Preservation of Ovarian Function and Hemostasis, and Its Safety of Surgiguard@ During Laparoscopic Ovarian Cystectomy
- ClinicalTrials.gov ID
- NCT03374397
- Acronym / sponsor ID
- PRAHA / 2017-1707
- Conditions
- Ovarian Cyst Benign
- Keywords
- Laparoscopic unilateral ovarian cystectomy, SurgiGuard, Hemostasis, Ovarian function preservation, Bipolar electrocauterization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 6 Dec 2017 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 15 Dec 2017 (actual)
- 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.
The purpose of this study is to compare hemostasis, ovarian function preservation effect, and safety about intraoperative bleeding with SurgiGuard@ in women who underwent laparoscopic unilateral ovarian cystectomy
Detailed description
In women who underwent laparoscopic unilateral ovarian cystectomy, the effect of SurgiGuard@ was assessed by randomization, using SurgiGuard@ and Bipolar electro cauterization, followed by comparative evaluation of hemostasis, ovarian function preservation, safety using postoperative Hb, anti-mullerian hormone (AMH), pelvis ultrasonography (USG), and physical examination
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SurgiGuard | Active comparator | Drug: SurgiguardSurgiguard Non-woven Drug : SurgiGuard Non-woven 6g during surgery |
| Bipolar electrocauterization | No intervention | –Bipolar electrocauterization during surgery Drug(-) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female, 18 years ≤ Ages <45 years
- laparoscopic unilateral ovarian cystectomy scheduled patients with benign unilateral ovarian cyst confirmed by ultrasonography
- women with regular menstruation
- women with regular menstruation cycle from 21 days to 45 days
- Proper state for laparoscopic operation (American society of Anesthesiologists Physical Status classification 1 or 2)
Key exclusion criteria (9 listed)
- Patients without ovarian cyst
- Patients with malignant female genital disease
- Patients with bilateral ovarian cysts
- Age ≥ 45
- Pregnancy or lactating women
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 |
|---|---|---|
| SurgiguardAlso: laparoscopic unilateral ovarian cystectomyHemostasis with Surgiguard during laparoscopic unilateral ovarian cystectomy | Drug | SurgiGuard |
Primary outcome
Hemostasis
Time frame: post operative 48 hours later,1 week later, and 12 weeks later
Change of serum hemoglobin from baseline
2 secondary outcomes
Ovarian function preservation
Time frame: post operative 48 hours later,1 week later, and 12 weeks later
Volume of ovary
Time frame: post operative 48 hours later,1 week later, and 12 weeks later
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 10 Dec 2019.
- Derived from this study: PubMed 33875738Park SJ, Seol A, Lee N, Lee S, Kim HS; PRAHA Study Group. A randomized controlled trial of ovarian reserve preservation and hemostasis during ovarian cystectomy. Sci Rep. 2021 Apr 19;11(1):8495. doi: 10.1038/s41598-021-87965-7.
- Individual participant dataSharing planned: Undecided
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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.
Hee Seung Kim, MD/PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Surgiguard in people with Ovarian Cyst Benign, run by Seoul National University Hospital at 1 site in South Korea.
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 6 inclusion and 9 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 10 Dec 2019. 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 South Korea. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Hemostasis (time frame: post operative 48 hours later,1 week later, and 12 weeks later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03374397, which also lists 1 linked publication.
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 10 Dec 2019.