Laparoscopic Gynecological SurgeryCONTAINNCT04799210
Human Factors Actual-Use Clinical Protocol
A study testing Eximis CS (Contained Segmentation) System in people with Laparoscopic Gynecological Surgery, run by Eximis Surgical at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 49 years, women only
- Conditions the study is for
- Laparoscopic Gynecological Surgery
- What is being tested?
- Eximis CS (Contained Segmentation) System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 7 sitesUnited States
- Study dates
- 16 Sep 2021to 13 Dec 2021
- 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 21 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age >/= 21 and < 50 years.
- Planned laparoscopic hysterectomy or myomectomy.
- Tissue specimen is <11 cm in maximum diameter based on standard preoperative assessment.
- Pre-operative evaluation which may include imaging, cervical cancer screening, and endometrial biopsy has been completed.
- Signed informed consent.
- Willing to adhere to protocol requirements and complete follow-up.
Who cannot join
- Subject is post-menopausal, defined as amenorrhea >12 months in the absence of ovulation suppression.
- Known or suspected malignancy of gynecological origin as determined by standard clinical practice.
- Candidate for en bloc tissue removal, for example through the vagina or via a mini-laparotomy incision.
- Hemoglobin < 8 g/dl within 30 days prior to surgery.
- Subject has a current history of undiagnosed genital bleeding.
- Subject has an implanted electronic device where use of radiofrequency (RF) energy would be contraindicated (e.g., pacemaker, internal defibrillator).
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- Medical condition, surgical history, or intra-operative findings, which in the option of the investigator, precludes utilization of the Eximis CS System.
- Known allergy to polyurethane, polyethylene, thermoplastic fluoropolymer and/or chlorinated polyvinyl chloride.
- Concurrent participation in another therapeutic or interventional clinical trial with investigational pharmaceutical agent(s) or medical device(s) that could impact evaluation of this study as determined by the Investigator.
- Inability to comply with the study procedures or follow-up in the opinion of the investigator.
- Subject is pregnant.
- Intraoperative Exclusion: Abdominal wall thickness at the umbilicus incision site is > 8 cm.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
AdventHealth Medical Group Gynecologic Surgery at Celebration
Celebration, Florida, 34747
NorthShore University HealthSystem
Evanston, Illinois, 60201
Advanced Women's Health Institute
Greenwood Village, Colorado, 80111
Advanced Gynecologic Surgery Institute
Park Ridge, Illinois, 60068
Swor Women's Care
Sarasota, Florida, 34239
ProMedica Health System
Sylvania, Ohio, 43560
About this study
Official title: Human Factors Actual-Use Confirmatory Validation Study of the Eximis CS (Contained Segmentation) System ("Contain" Study)
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.
Read the detailed description
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.
- Conditions
- Laparoscopic Gynecological Surgery
- Being tested
- Eximis CS (Contained Segmentation) System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eximis CS (Contained Segmentation) SystemDevice
Also called Eximis CS, EX-900K-CLIN
Containment, segmentation and extraction of uterine tissue in pre-menopausal women undergoing laparoscopic hysterectomy or myomectomy for non-cancer indications.
| Study group | Role | What they receive |
|---|---|---|
| Human Factors Actual Use | Experimental | Confirm device use safety and effectiveness of the Eximis CS (Contained Segmentation) System in actual use Receives: Device: Eximis CS (Contained Segmentation) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of procedures where all critical tasks related to the Eximis CS are performed without serious use error.
Primary Endpoint
Measured: Through study completion, anticipated to be 4-6 months
Secondary outcomes (5)
Number of procedures successfully completed with use of the Eximis CS device.
Secondary Endpoint
Measured: Through study completion, anticipated to be 4-6 months
Number of Capture Bags with breach of containment.
Secondary Endpoint
Measured: Through study completion, anticipated to be 4-6 months
The number and severity of user adverse events caused by use error.
Secondary Endpoint
Measured: Day of surgery
The number and severity of subject adverse events caused by use error.
Secondary Endpoint
Measured: Minimum 30 days (Standard of care follow-up 4-6 weeks)
All other adverse events.
Secondary Endpoint
Measured: Minimum 30 days (Standard of care follow-up 4-6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start16 Sep 2021
- Primary completion13 Dec 2021
- Study completion13 Dec 2021
Why it stopped: Device performance was not as anticipated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Gynecological 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
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eximis Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sawsan As-Sanie, MD, MPH, Principal investigator, Women's Hospital, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799210
- Sponsor's protocol ID
- CIP2020-001
- Acronym
- CONTAIN
- Status last verified
- Feb 2022
- First submitted
- 10 Mar 2021
- Last updated
- 14 Feb 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 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Factors Actual-Use Confirmatory Validation Study of the Eximis CS (Contained Segmentation) System ("Contain" Study)
- ClinicalTrials.gov ID
- NCT04799210
- Acronym / sponsor ID
- CONTAIN / CIP2020-001
- Conditions
- Laparoscopic Gynecological Surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Device performance was not as anticipated.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Eximis SurgicalIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 16 Mar 2021 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Human Factors Actual Use | Experimental | Device: Eximis CS (Contained Segmentation) SystemConfirm device use safety and effectiveness of the Eximis CS (Contained Segmentation) System in actual use |
Who may qualify
- Ages
- 21 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age >/= 21 and < 50 years.
- Planned laparoscopic hysterectomy or myomectomy.
- Tissue specimen is <11 cm in maximum diameter based on standard preoperative assessment.
- Pre-operative evaluation which may include imaging, cervical cancer screening, and endometrial biopsy has been completed.
- Signed informed consent.
Key exclusion criteria (12 listed)
- Subject is post-menopausal, defined as amenorrhea >12 months in the absence of ovulation suppression.
- Known or suspected malignancy of gynecological origin as determined by standard clinical practice.
- Candidate for en bloc tissue removal, for example through the vagina or via a mini-laparotomy incision.
- Hemoglobin < 8 g/dl within 30 days prior to surgery.
- Subject has a current history of undiagnosed genital bleeding.
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 |
|---|---|---|
| Eximis CS (Contained Segmentation) SystemAlso: Eximis CS, EX-900K-CLINContainment, segmentation and extraction of uterine tissue in pre-menopausal women undergoing laparoscopic hysterectomy or myomectomy for non-cancer indications. | Device | Human Factors Actual Use |
Primary outcome
The number of procedures where all critical tasks related to the Eximis CS are performed without serious use error.
Time frame: Through study completion, anticipated to be 4-6 months
Primary Endpoint
5 secondary outcomes
Number of procedures successfully completed with use of the Eximis CS device.
Time frame: Through study completion, anticipated to be 4-6 months
Number of Capture Bags with breach of containment.
Time frame: Through study completion, anticipated to be 4-6 months
The number and severity of user adverse events caused by use error.
Time frame: Day of surgery
The number and severity of subject adverse events caused by use error.
Time frame: Minimum 30 days (Standard of care follow-up 4-6 weeks)
All other adverse events.
Time frame: Minimum 30 days (Standard of care follow-up 4-6 weeks)
Results and safety
The study was stopped early (reason given: Device performance was not as anticipated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 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.
Sawsan As-Sanie, MD, MPH principal investigator
Women's Hospital, University of Michigan
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eximis CS (Contained Segmentation) System in people with Laparoscopic Gynecological Surgery, run by Eximis Surgical at 7 sites in United States.
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 12 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: stopped early, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early (reason given: Device performance was not as anticipated.). Results are not available in the source record.
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 number of procedures where all critical tasks related to the Eximis CS are performed without serious use error. (time frame: Through study completion, anticipated to be 4-6 months). 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 14 Feb 2022.