Gynecologic SurgeryNCT03216772
Safety and Efficacy of Using PK Morcellator With Pneumoliner Containment Hysterectomy
A study testing Olympus PK Morcellator in PneumoLiner in people with Gynecologic Surgery, run by Olympus Surgical Technologies Europe.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 35 to 50 years, women only
- Conditions the study is for
- Gynecologic Surgery
- What is being tested?
- Olympus PK Morcellator in PneumoLiner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2018to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pre- and Peri-menopausal woman patient age 35-50 years
- Women with fibroids and indication for laparoscopic hysterectomy at which a morcellators for cutting and extraction of tissue is required.
- Normal Pap test result in the last year
- Hemoglobin level of 10.0 g/dL or more at the time of treatment
- Subject able to comprehend and give informed consent for participation in this study
- Signed informed consent form
Who cannot join
- Patient is not considered suitable for a laparoscopic hysterectomy procedure
- Women with:
- Known or suspected gynecologic malignancy
- Known cervical dysplasia
- Postmenopausal women
- Undiagnosed vaginal bleeding
Show all 20Show fewer
- Abdominal wall thickness is larger than 10 cm
- Atypical hyperplasia or malignancy in preoperative endometrial biopsy.
- Known cognitive disorder
- HIV or any other immunosuppressive disorder
- Liver disease
- Renal failure (Serum creatinine above 2.5 dL/ml)
- Cardiopulmonary disease contraindicating laparoscopic surgery
- History or evidence of gynecologic malignancy within the past five years
- Pace maker, internal defibrillator/cardio converter
- Impaired coagulation parameters
- Previous extensive pelvic surgery
- Psychological/psychiatric disease
- Contraindications to anesthesia or abdominal surgery.
- Concurrent participation in any other clinical study
About this study
Official title: Safety and Efficacy of Using PK Morcellator With Pneumoliner Bag for Laparoscopic Morcellation With Laparoscopic Instrument for Tissue Containment and Removal During Laparoscopic Supracervical Hysterectomy or Total Laparoscopic Hysterectomy
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)
- Conditions
- Gynecologic Surgery
- Being tested
- Olympus PK Morcellator in PneumoLiner
- Keywords
- Gynecologic Surgery, larscopy, morcellation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olympus PK Morcellator in PneumoLinerDevice
Laparoscopic Supracervical Hysterectomy (LSH) or Total Laparoscopic Hysterectomy (TLH) using Olympus PK Morcellator in PneumoLiner containment device
| Study group | Role | What they receive |
|---|---|---|
| Olympus PK Morcellator in PneumoLiner | Experimental | Laparoscopic Supracervical Hysterectomy (LSH) or Total Laparoscopic Hysterectomy (TLH) using the Olympus PK Morcellator in PneumoLiner containment device Receives: Device: Olympus PK Morcellator in PneumoLiner |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- Failure is defined as "disruption of the isolation bag (using dye leak testing) or visible tissue dissemination".
- Patient is defined "success" if no failure was detected as a result of the procedure.
- Study safety success will be declared if no more than 1 failure (bag rapture) will be observed in 140 procedures.
Measured: End of study - approximately two years
Secondary outcomes (7)
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.
Measured: End of study - approximately two years
Intra- or post-operative complications
Intra or post complications rate (e.g. urinary, intestinal or nerve injury)
Measured: End of study - approximately two years
Mean procedure time
Mean procedure time will be measured by hour/minutes.
Measured: End of study - approximately two years
Estimated blood loss during operation
Blood loss during operation will be measured by volume (mL)
Measured: End of study - approximately two years
Post-operative pain
Post-operative pain will be measured by Visual Analog Score - VAS
Measured: End of study - approximately two years
Hospitalization length
Hospitalization length will be measured by days
Measured: End of study - approximately two years
Specimen weight
Specimen will be measured by weight (gr)
Measured: End of study - approximately two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start20 Jan 2018
- Primary completionSep 2021 (estimated)
- Study completionFeb 2022 (estimated)
Why it stopped: Study was withdrawn for organizational reasons, not due to safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olympus Surgical Technologies Europe
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erin Carey, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216772
- Sponsor's protocol ID
- PK MORCELLATOR-LSH-01
- Status last verified
- Jul 2022
- First submitted
- 8 Jul 2017
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Using PK Morcellator With Pneumoliner Bag for Laparoscopic Morcellation With Laparoscopic Instrument for Tissue Containment and Removal During Laparoscopic Supracervical Hysterectomy or Total Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT03216772
- Acronym / sponsor ID
- PK MORCELLATOR-LSH-01
- Conditions
- Gynecologic Surgery
- Keywords
- Gynecologic Surgery, larscopy, morcellation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was withdrawn for organizational reasons, not due to safety concerns.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Olympus Surgical Technologies EuropeIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2018 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 13 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Olympus PK Morcellator in PneumoLiner | Experimental | Device: Olympus PK Morcellator in PneumoLinerLaparoscopic Supracervical Hysterectomy (LSH) or Total Laparoscopic Hysterectomy (TLH) using the Olympus PK Morcellator in PneumoLiner containment device |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pre- and Peri-menopausal woman patient age 35-50 years
- Women with fibroids and indication for laparoscopic hysterectomy at which a morcellators for cutting and extraction of tissue is required.
- Normal Pap test result in the last year
- Hemoglobin level of 10.0 g/dL or more at the time of treatment
- Subject able to comprehend and give informed consent for participation in this study
Key exclusion criteria (20 listed)
- Patient is not considered suitable for a laparoscopic hysterectomy procedure
- Women with:
- Known or suspected gynecologic malignancy
- Known cervical dysplasia
- Postmenopausal women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olympus PK Morcellator in PneumoLinerLaparoscopic Supracervical Hysterectomy (LSH) or Total Laparoscopic Hysterectomy (TLH) using Olympus PK Morcellator in PneumoLiner containment device | Device | Olympus PK Morcellator in PneumoLiner |
Primary outcome
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).
Time frame: End of study - approximately two years
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. * Failure is defined as "disruption of the isolation bag (using dye leak testing) or visible tissue dissemination". * Patient is defined "success" if no failure was detected as a result of the procedure. * Study safety success will be declared if no more than 1 failure (bag rapture) will be observed in 140 procedures.
7 secondary outcomes
The efficacy of using PK MORCELLATOR in conjunction with the PneumoLiner containment device
Time frame: End of study - approximately two years
Intra- or post-operative complications
Time frame: End of study - approximately two years
Mean procedure time
Time frame: End of study - approximately two years
Estimated blood loss during operation
Time frame: End of study - approximately two years
Post-operative pain
Time frame: End of study - approximately two years
Hospitalization length
Time frame: End of study - approximately two years
Specimen weight
Time frame: End of study - approximately two years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Carey, MD principal investigator
University of North Carolina, Chapel Hill
Questions about this trial
What is this clinical trial studying?
A study testing Olympus PK Morcellator in PneumoLiner in people with Gynecologic Surgery, run by Olympus Surgical Technologies Europe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: End of study - approximately two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.