Menorrhagia Clinical Trial
Official title:
A Prospective, Observational, Multi-center Study to Gather Real World Use Data on the Effectiveness, Safety, and Site-of-service of the Cerene Device
Channel Medsystems, Inc., the manufacturer of the Cerene® Cryotherapy Device (Cerene), is initiating a prospective, observational registry, the Progress registry, to gather data during real world utilization of the Cerene® Cryotherapy Device (Cerene). The primary objective of this registry is to bridge the gap between clinical results and outcomes achieved and reported during the pivotal study of Cerene and those obtained during its real-world use.
Cerene was approved by the FDA in March 2019 for endometrial cryoablation in premenopausal women with heavy menstrual bleeding due to benign causes for whom child bearing is complete. The primary objective of the Progress registry is to bridge the gap between clinical results and outcomes reported during the pivotal study of Cerene (the CLARITY Study) and those observed during its real-world use. The Progress registry will gather prospective, observational data on up to 300 women that underwent a Cerene treatment. Patients and physicians will complete surveys. Surveys will include patient demographic characteristics and quality of life measures at baseline, procedural details, and post-operative clinical outcomes and quality of life measures. Patient participation is expected to last approximately 13 months, from the time of patient enrollment to 12 months post treatment. The study will end after the last participating patient in completes her 12 month visit. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02824224 -
Tamoxifen to Reduce Unscheduled Bleeding in New Users of the Levonorgestrel-releasing Intrauterine System (LNG-IUS)
|
Phase 4 | |
| Withdrawn |
NCT01651468 -
The Effect of the Nutraceutical "Hemofix" on the Coagulation System
|
N/A | |
| Recruiting |
NCT02616731 -
Oral Tranexamic Acid Versus Diosmin for Treatment of Menorrhagia in Women Using Copper IUD
|
Phase 1/Phase 2 | |
| Terminated |
NCT02087228 -
Evaluation of the Endometrial Cavity After Endometrial Ablation
|
N/A | |
| Withdrawn |
NCT00953641 -
Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy
|
Phase 3 | |
| Completed |
NCT01436903 -
Chances for Success of CavatermTM Surgery as a Function of Uterus Probe Length
|
Phase 4 | |
| Withdrawn |
NCT00768742 -
Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study
|
N/A | |
| Completed |
NCT00156195 -
Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids
|
Phase 3 | |
| Completed |
NCT00152256 -
A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids
|
Phase 3 | |
| Completed |
NCT00160381 -
A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids
|
Phase 3 | |
| Completed |
NCT02228174 -
Sonography Guided Transcervical Ablation of Uterine Fibroids
|
N/A | |
| Terminated |
NCT01969396 -
Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology
|
N/A | |
| Completed |
NCT00393198 -
Bleeding Pattern and User Satisfaction During Second Consecutive MIRENA® in Contraception and Treatment of Menorrhagia
|
Phase 4 | |
| Completed |
NCT00386308 -
Efficacy and Safety Study of XP12B in Women With Menorrhagia
|
Phase 3 | |
| Completed |
NCT00966264 -
Hysterectomy and Levonorgestrel Releasing Intrauterine System (LNG-IUS) in the Treatment of Menorrhagia
|
Phase 3 | |
| Completed |
NCT00904709 -
The Assessment of Tranexamic Acid in Women With Menorrhagia Who Have Bleeding Disorders
|
Phase 4 | |
| Recruiting |
NCT03670680 -
Efficiency of Lina LibrataTM System
|
N/A | |
| Completed |
NCT02584088 -
Ultrasound Appearance of the Endometrium Post Radio-Frequency Ablation
|
||
| Completed |
NCT02835391 -
PerClot Compared to Usual Care in Gynaecology Procedures
|
N/A | |
| Completed |
NCT02304510 -
Prevalence of Heavy Menstrual Bleeding in Female Population Living in Beijing
|