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Study was withdrawn for organizational reasons, not due to safety concerns.
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The study is designed to evaluate the safety of performing in-bag morcellation of uterus tissues during laparoscopic hysterectomy (LSH or TLH). Pre- and perimenopausal women, aged 35-50 undergoing laparoscopic supracervical hysterectomy (LSH) or total laparoscopic hysterectomy (TLH)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olympus PK Morcellator in PneumoLiner | Experimental | Laparoscopic Supracervical Hysterectomy (LSH) or Total Laparoscopic Hysterectomy (TLH) using the Olympus PK Morcellator in PneumoLiner containment device |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olympus PK Morcellator in PneumoLiner | Device | Laparoscopic Supracervical Hysterectomy (LSH) or Total Laparoscopic Hysterectomy (TLH) using Olympus PK Morcellator in PneumoLiner containment device |
| Measure | Description | Time Frame |
|---|---|---|
| The safety of using the PK MORCELLATOR in conjunction with the PneumoLiner containment device for contained cutting and extracting tissue during laparoscopic supracervical hysterectomy (LSH) or total laparoscopic hysterectomy (TLH). | The safety of using the PK MORCELLATOR within the PneumoLiner containment bag for cutting and extracting tissue during LSH or TLH procedure will be determined by the probability of failure during in-bag morcellation procedure.
| End of study - approximately two years |
| Measure | Description | Time Frame |
|---|---|---|
| The efficacy of using PK MORCELLATOR in conjunction with the PneumoLiner containment device | Ease of use of the PK MORCELLATOR in conjunction with the PneumoLiner containment device for LSH or TLH. Ease of use will be measured by designated Satisfaction Questionnaire. | End of study - approximately two years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erin Carey, MD | University of North Carolina, Chapel Hill | Principal Investigator |
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| Intra- or post-operative complications |
Intra or post complications rate (e.g. urinary, intestinal or nerve injury) |
| End of study - approximately two years |
| Mean procedure time | Mean procedure time will be measured by hour/minutes. | End of study - approximately two years |
| Estimated blood loss during operation | Blood loss during operation will be measured by volume (mL) | End of study - approximately two years |
| Post-operative pain | Post-operative pain will be measured by Visual Analog Score - VAS | End of study - approximately two years |
| Hospitalization length | Hospitalization length will be measured by days | End of study - approximately two years |
| Specimen weight | Specimen will be measured by weight (gr) | End of study - approximately two years |