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Device performance was not as anticipated.
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The purpose of this study is to confirm device use safety and effectiveness of the Eximis CS (Contained Segmentation) System in actual use by representative users, use, and use environments as required for regulatory agency clearance for commercial use.
This is a prospective, multi-center, single-arm study to confirm device use safety and effectiveness in an actual use setting when utilized by gynecological surgeons during surgery for containment, segmentation and extraction of uterine tissue in pre-menopausal women undergoing laparoscopic hysterectomy or myomectomy for non-cancer indications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human Factors Actual Use | Experimental | Confirm device use safety and effectiveness of the Eximis CS (Contained Segmentation) System in actual use |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eximis CS (Contained Segmentation) System | Device | Containment, segmentation and extraction of uterine tissue in pre-menopausal women undergoing laparoscopic hysterectomy or myomectomy for non-cancer indications. |
| Measure | Description | Time Frame |
|---|---|---|
| The number of procedures where all critical tasks related to the Eximis CS are performed without serious use error. | Primary Endpoint | Through study completion, anticipated to be 4-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of procedures successfully completed with use of the Eximis CS device. | Secondary Endpoint | Through study completion, anticipated to be 4-6 months |
| Number of Capture Bags with breach of containment. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of the segmentation/extraction procedure (from insertion of the Eximis CS deployment instrument into the abdomen until removal of the Eximis CS Capture Bag from the abdomen). | For Informal Evaluation | Day of surgery |
| Duration of the surgical procedure (from skin incision to skin closure). |
Inclusion Criteria:
Exclusion Criteria:
Pre-menopausal women undergoing laparoscopic hysterectomy or myomectomy for non-cancer indications.
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| Name | Affiliation | Role |
|---|---|---|
| Sawsan As-Sanie, MD, MPH | Women's Hospital, University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Women's Health Institute | Greenwood Village | Colorado | 80111 | United States | ||
| AdventHealth Medical Group Gynecologic Surgery at Celebration |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 3, 2023 | Jan 25, 2023 | 5 | ||
| Jan 27, 2023 |
| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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Single Group Assignment
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|
Secondary Endpoint
| Through study completion, anticipated to be 4-6 months |
| The number and severity of user adverse events caused by use error. | Secondary Endpoint | Day of surgery |
| The number and severity of subject adverse events caused by use error. | Secondary Endpoint | Minimum 30 days (Standard of care follow-up 4-6 weeks) |
| All other adverse events. | Secondary Endpoint | Minimum 30 days (Standard of care follow-up 4-6 weeks) |
For Informal Evaluation |
| Day of surgery |
| Length of incision (mm) used for the Eximis CS device at procedure end (removal of Eximis CS Capture Bag). | For Informal Evaluation | Day of surgery |
| Removed tissue weight (grams). | For Informal Evaluation | Day of surgery |
| Number of extracted tissue segments per subject. | For Informal Evaluation | Day of surgery |
| The size (mm) of the largest segment will be recorded, defined as the segment with the largest cross-sectional area of the surface that is parallel with the incision opening. | For Informal Evaluation | Day of surgery |
| Subject's pathology results of the extracted tissue and pathologist assessment of radiofrequency (RF) energy impact to the tissue, if any, from use of the Eximis CS device. | For Informal Evaluation | Day of surgery |
| Celebration |
| Florida |
| 34747 |
| United States |
| Swor Women's Care | Sarasota | Florida | 34239 | United States |
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | United States |
| Advanced Gynecologic Surgery Institute | Park Ridge | Illinois | 60068 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| ProMedica Health System | Sylvania | Ohio | 43560 | United States |
| Feb 23, 2023 |
| 6 |