Clinical trials: Myoma
Fibroid, Myoma
Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy
This study is planned as a prospective, randomised, parallel, controlled, multi-centre, open label, comparative evaluation of SprayShield™ Adhesion Barrier plus good surgical technique, versus good surgical technique alone, with…
- Conditions
- Fibroid, Myoma, Leiomyoma
- Trial name
- NCT00891657
- Testing
- SprayShield™
- Where
- Germany
- Volunteers
- 15 people
- Sponsor
- Integra LifeSciences Corporation
Symptomatic Uterine Fibroids
Post Market TRUST - U.S.A. Study
This Post Market study is being conducted to compare the direct and indirect cost of three approaches (GFA, myomectomy, and uterine artery embolization) for the treatment of symptomatic uterine fibroids.
- Trial name
- NCT02163525
- Testing
- Global Fibroid Ablation (GFA), Abdominal or Laparoscopic Myomectomy, Uterine Artery Embolization (UAE)
- Where
- 9 sites in United States
- Volunteers
- 114 people
- Sponsor
- Acessa Health, Inc.
Myoma of Uterus
Clinical Trial to Evaluate the Efficacy and Safety of DW4902
A Multi-center, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory, Phase II Clinical Trial for the Efficacy Investigation and Safety Evaluation of DW4902 in Patients with Uterine Fibroids.
- Trial name
- NCT07319520
- Testing
- DW4902 160mg, DW4902 240mg, DW4902 320mg
- Where
- South Korea
- Volunteers
- 71 people
- Sponsor
- Daewon Pharmaceutical Co., Ltd.
Uterine Fibroids
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
This is a multicentre, Phase III, efficacy and safety open-label study with PGL4001 10mg once daily for 3 months, blinded towards the administration of progestin or placebo after end of PGL4001 treatment.
- Trial name
- PEARLIII (NCT01156857)
- Testing
- PGL4001, progestin
- Where
- 23 sites in Austria, Belgium and 2 more
- Volunteers
- 209 people
- Sponsor
- PregLem SA
Uterine Fibroids
Post Market TRUST Study
This Post Market study is being conducted to compare the direct and indirect cost of three approaches (GFA, myomectomy, and uterine artery embolization) for the treatment of symptomatic uterine fibroids.
- Trial name
- TRUST (NCT01563783)
- Testing
- Global Fibroid Ablation (GFA), Abdominal or Laparoscopic Myomectomy, Uterine Artery Embolization (UAE)
- Where
- Canada
- Volunteers
- 84 people
- Sponsor
- Acessa Health, Inc.
Symptomatic Uterine Fibroids
Laparoscopic Cryoablation of Uterine Fibroids
The goal of this study is to evaluate the safety \& efficacy of cryoablation using IceCure medical's IceSense3™ device for the treatment of symptomatic uterine fibroids in a percutaneous lap-assisted approach.
- Trial name
- UFREEZE-01 (NCT01735812)
- Testing
- IceSense3 system
- Where
- Israel
- Sponsor
- IceCure Medical Ltd.
Uterine Myomas
PGL4001 Versus GnRH-agonist in Uterine Myomas
This trial will assess the efficacy and safety of PGL4001 versus GnRH agonist, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.
- Trial name
- PEARLII (NCT00740831)
- Testing
- PGL4001, leuprorelin
- Where
- 46 sites in Austria, Belgium and 7 more
- Volunteers
- 301 people
- Sponsor
- PregLem SA
Myomas, Ovary Cysts
The Efficacy and Safety Study of a New Cross-linked Hyaluronan Hydrogel in the Reduction of Postsurgical Peritoneal Adhesions
The purpose of this study was to determine whether the new crosslinked hyaluronan hydrogel was safe to use, and was effective for the prevention/reduction of adhesion formation following gynecological surgery
- Conditions
- Myomas, Ovary Cysts, Endometriotic Cysts, Adhesions
- Trial name
- BAP (NCT02166554)
- Testing
- Saline, Cross-linked Hyaluronan Hydrogel
- Where
- 7 sites in China
- Volunteers
- 216 people
- Sponsor
- BioRegen Biomedical (Changzhou) Co., Ltd
Uterine Myomas
PGL4001 Versus Placebo in Uterine Myomas
This trial will assess the efficacy and safety of PGL4001 with concomitant iron administration versus placebo with concomitant iron administration, over a 3-month period for the pre-operative treatment of pre-menopausal women…
- Trial name
- PEARLI (NCT00755755)
- Testing
- PGL4001 (ulipristal) and iron
- Where
- 38 sites in Czechia, Hungary and 4 more
- Volunteers
- 241 people
- Sponsor
- PregLem SA
UTERINE MYOMAS
Assessment of the Manageability and Safety of ADBLOCK Adhesion Barrier System in Laparoscopic Gynaecological Surgery
Adhesions are the most frequent complication of abdominopelvic surgery. They are internal scar tissues which form as a result of surgery which may abnormally join together what were once separate tissues and organs.
- Trial name
- ADBEE (NCT01745432)
- Testing
- ADBLOCK
- Where
- 3 sites in Germany
- Volunteers
- 30 people
- Sponsor
- Terumo Europe N.V.
Uterine Myoma, Uterine Fibroid
Comparison of Pain After Uterine Artery Embolization Using Gelatin Microsphere or Tris-acryl Gelatin Microsphere
This study is a prospective and randomized investigation planned to compare pain after uterine artery embolization using Gelatin microsphere or tris-acryl gelatin microsphere in 60 patients with symptomatic fibroids.
- Trial name
- NCT05086770
- Testing
- Gelatin microsphere (Nexsphere™), Embosphere
- Where
- South Korea
- Volunteers
- 60 people
- Sponsor
- Next Biomedical Co., Ltd.
Myoma;Uterus, Fibroid Uterus
Open Label Immunotherapy of Myoma
Myoma of the uterus or uterine fibroids are benign tumors that appears in the myometrium or the muscular layer of the uterus. It is one of the most common diseases in pre-climax women, reaching 12-25% of all gynecological…
- Conditions
- Myoma;Uterus, Fibroid Uterus, Leiomyoma, Fibroma
- Trial name
- V3-myoma (NCT03550703)
- Testing
- V3-Myoma
- Where
- Mongolia
- Volunteers
- 30 people
- Sponsor
- Immunitor LLC
Myoma
Safety and Efficacy Study of a Hydrogel, Applied Following Removal of Myomas During Gynecologic Surgery, Administered for the Prevention/Reduction of Postoperative Adhesion Formation
The purpose of this study was to determine whether the adhesion prevention gel was safe to use, and was effective for the prevention/reduction of adhesion formation that typically occurs following gynecological surgery to remove…
- Trial name
- NCT00562471
- Testing
- Adhibit Adhesion Prevention Gel, Standard of Care Comparator
- Where
- 6 sites in Canada, Germany and 1 more
- Volunteers
- 76 people
- Sponsor
- Angiotech Pharmaceuticals
Menorrhagia
Sonography Guided Transcervical Ablation of Uterine Fibroids
The objective of this study is to establish the safety and effectiveness of the Sonata® System in the treatment of symptomatic uterine fibroids.
- Trial name
- SONATA (NCT02228174)
- Testing
- Intrauterine Ultrasound-Guided Radiofreq. Ablation System
- Where
- 23 sites in United States, Mexico
- Volunteers
- 147 people
- Sponsor
- Gynesonics
Uterine Leiomyoma
Directed Ablation of Uterine Fibroids Using a Noninvasive Approach
The purpose of this clinical study is to assess the safety and effectiveness of the Mirabilis System for treating uterine fibroids in women who are seeking relief from fibroid-related abnormal uterine bleeding but want to avoid…
- Trial name
- DIANA (NCT03219385)
- Testing
- Mirabilis System
- Volunteers
- 180 people
- Sponsor
- Mirabilis Medica, Inc.
Uterine Myoma
A Study to Compare the Pharmacokinetics and Safety/Tolerability of BR-UPS (Ulipristal Acetate) 5 mg Tablet With Inisia (Ulipristal Acetate) 5 mg Tablet
The purpose of this study is to evaluate the Pharmacokinetics and Safety / Tolerability of BR-UPS (Ulipristal acetate) 5 mg tablet with Inisia (Ulipristal acetate) 5 mg tablet in healthy female volunteers
- Trial name
- NCT03156127
- Testing
- BR-UPS 5 mg tablet, Inisia 5 mg tablet
- Where
- South Korea
- Volunteers
- healthy volunteers welcome
- Sponsor
- Boryung Pharmaceutical Co., Ltd
Uterine Fibroids
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII-extension Study)
This is the long-term extension of a phase III, efficacy and safety open-label (protocol PGL09-026) with PGL4001 10mg tablets once daily for three months, blinded towards the administration of progestin or placebo tablets after…
- Trial name
- NCT01252069
- Testing
- PGL4001, progestin, drug free period
- Where
- 18 sites in Austria, Belgium and 2 more
- Volunteers
- 132 people
- Sponsor
- PregLem SA
Uterine Fibroid, Myoma
OCL 500 Treatment of Women With Symptomatic Uterine Fibroids
This is a prospective, open-label, single-arm, safety and effectiveness study of Occlusin 500 microspheres in women with symptomatic uterine fibroids.
- Conditions
- Uterine Fibroid, Myoma, Leiomyoma
- Trial name
- NCT03427671
- Testing
- Occlusin 500 Microspheres
- Where
- Canada
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- IMBiotechnologies Ltd.
Uterine Fibroids
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
This is a phase III, multicentre, long-term open-label extension of the phase III study: Pearl IIIextension (PGL09-027). During Pearl III (PGL09-026) and subsequent Pearl III extension (PGL09-027), patients have been exposed to a…
- Trial name
- PEARLext2 (NCT01642472)
- Testing
- Ulipristal Acetate - open label
- Where
- 16 sites in Austria, Belgium and 2 more
- Volunteers
- 64 people
- Sponsor
- PregLem SA
Uterine Fibroids, Uterine Myomas
Laparoscopic Radiofrequency Ablation (RFA) of Symptomatic Uterine Fibroids
The purpose of this study is to demonstrate the safety and effectiveness of radiofrequency ablation (RFA) using the Halt System for the treatment of patients with symptomatic uterine fibroids.
- Trial name
- Halt (NCT00874029)
- Testing
- Halt Procedure
- Where
- 11 sites in United States, Guatemala and 1 more
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- Acessa Health, Inc.