A Phase 3 interventional study of Surgiguard in Ovarian Cyst Benign, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-12-10.
Sponsored by Seoul National University Hospital · Phase 3, Interventional, and Treatment
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
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
80 studies on the registry are indexed under Ovarian Cysts; 16 are open to participants now.
This study's enrollment of 52 is below the median of 74 across 51 interventional studies indexed under Ovarian Cysts.
Browse Ovarian Cysts studies →Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Surgiguard Non-woven Drug : SurgiGuard Non-woven 6g during surgery
Drug: Surgiguard
Bipolar electrocauterization during surgery Drug(-)
Hemostasis with Surgiguard during laparoscopic unilateral ovarian cystectomy
Also known as: laparoscopic unilateral ovarian cystectomy
Hemostasis
Change of serum hemoglobin from baseline
Time frame: post operative 48 hours later,1 week later, and 12 weeks later
Ovarian function preservation
Change of serum AMH from baseline
Time frame: post operative 48 hours later,1 week later, and 12 weeks later
Volume of ovary
ovarian volume measured by ultrasonography
Time frame: post operative 48 hours later,1 week later, and 12 weeks later
Plan to share: Undecided
Ran from Dec 2017 to primary completion in Aug 2019, 20 months.
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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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