Menorrhagia Clinical Trial
Official title:
Evaluation of the Safety of NovaSure in the Presence of Essure Following the Essure Confirmation Test (ECT) Post-Approval Study
This post approval, observational study is being conducted to further evaluate the safety of the NovaSure Endometrial Ablation System when it is performed in the presence of Essure micro-inserts.
A prospective, single arm, multi-center, post approval study that is designed to provide additional information on the safety of performing a NovaSure Impedence Controlled Endometrial Ablation System in the presence of Essure Permanent Birth Control System, following the Essure Confirmation Test has confirmed both bilateral tubal occlusion and the satisfactory location of the Essure micro-inserts. The study will be conducted at up to 15 clinical sites and enroll 318 patients. Patients who meet the inclusion and none of the exclusion criteria will have the study explained to them and be invited to participate. Enrolled subjects will have baseline data collected at the time of their NovaSure procedure and will be followed for 1 month after the NovaSure procedure to be assessed for adverse events. ;
| 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| Withdrawn |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| Withdrawn |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| Withdrawn |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
|