Laparoscopic Gynecological Surgical ProceduresNCT06572163
Clinical Validation Study of the Eximis CS (Contained Segmentation) System
A study testing Eximis CS (Contained Segmentation) System in people with Laparoscopic Gynecological Surgical Procedures, run by Eximis Surgical at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate device safety and effectiveness of the Eximis CS System. Read more about this study
- Who is it for?
- Ages 21 to 49 years, women only
- Conditions the study is for
- Laparoscopic Gynecological Surgical Procedures
- 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
- 23 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Sep 2024to 25 Oct 2025
- 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
- Planned laparoscopic hysterectomy or myomectomy. Tissue specimen size is greater than 6 cm in diameter, less than 13 cm in the longest dimension, and at most 10 cm in the second longest dimension, based on 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).
- 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.
Show all 10Show fewer
- 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 exceeds 6 cm.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Maimonides Medical Center
Brooklyn, New York, 11219
Advent Health, 410 Celebration Place
Celebration, Florida, 34747
Rosemark Womens Care Specialists
Idaho Falls, Idaho, 83404
Oregon Health and Science University School of Medicine
Portland, Oregon, 97239
About this study
The purpose of this study is to evaluate device safety and effectiveness of the Eximis CS System.
Read the detailed description
This is a prospective, multi-center, single-arm study to confirm device safety and effectiveness when utilized for containment, segmentation, and extraction of uterine tissue in pre-menopausal women undergoing laparoscopic hysterectomy or myomectomy for non-cancer indications.
Eligible subjects who have signed an informed consent form (ICF) will be enrolled. Subjects will be sequentially enrolled and assigned a study identification number. Surgeons will also be assigned a unique number.
Subjects will undergo the standard of care regarding all aspects of the pre-operative, surgical, and follow-up procedures. The aspect unique to this study is the capture, segmentation, and extraction of the target tissue will utilize one integrated device, the Eximis CS System, which segments tissue via segmenting wires using RF energy. The device is not intended to provide any therapeutic effect.
All subjects will be followed for safety through two post-procedure follow-up visits. One will be scheduled at a minimum of 14 days and a maximum of 21 days post-operatively. The second will be a follow-up phone call scheduled at a minimum of 30 days and a maximum of 45 days post-operatively.
- 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
The Eximis CS System is an integrated system consisting of a 900 mL Capture Bag, Inflation Mechanism, two Eximis Segmenters, and the Eximis RF Generator.
| Study group | Role | What they receive |
|---|---|---|
| Surgical | Other | containment, segmentation, and extraction of uterine tissue Receives: Device: Eximis CS (Contained Segmentation) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance
Percentage of procedures successfully completed with use of the Eximis CS device per the Instructions for Use and without breach of the containment bag.
Measured: 2 months
Secondary outcomes (1)
Usability
Percentage of procedures where all critical tasks related to the Eximis CS are performed without observed failure or omission.
Percentage of procedures requiring critical troubleshooting steps (i.e., extending an incision, employing alternate tissue removal techniques) per the Instructions for Use Percentage of procedures requiring other troubleshooting steps (i.e., replacing the RF Generator, Segmenter, or Capture Bag; cutting Segmenter wires; responding to an alarm or information signal) per the Instructions for Use
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start20 Sep 2024
- Primary completion1 Sep 2025
- Study completion25 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Gynecological Surgical ProceduresStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eximis Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Proxima CRO
- Responsible party
- Sponsor
- Investigators
- Scott Chudnoff, MD, Principal investigator, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572163
- Sponsor's protocol ID
- CP2024-001
- Status last verified
- Oct 2025
- First submitted
- 23 Aug 2024
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation Study of the Eximis CS (Contained Segmentation) System
- ClinicalTrials.gov ID
- NCT06572163
- Acronym / sponsor ID
- CP2024-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Eximis SurgicalIndustry (pharma, biotech, devices)
- Collaborators
- Proxima CRO
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 25 Oct 2025 (actual)
- First posted
- 27 Aug 2024 (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 evaluate device safety and effectiveness of the Eximis CS System.
Detailed description
This is a prospective, multi-center, single-arm study to confirm device safety and effectiveness when utilized for containment, segmentation, and extraction of uterine tissue in pre-menopausal women undergoing laparoscopic hysterectomy or myomectomy for non-cancer indications.
Eligible subjects who have signed an informed consent form (ICF) will be enrolled. Subjects will be sequentially enrolled and assigned a study identification number. Surgeons will also be assigned a unique number.
Subjects will undergo the standard of care regarding all aspects of the pre-operative, surgical, and follow-up procedures. The aspect unique to this study is the capture, segmentation, and extraction of the target tissue will utilize one integrated device, the Eximis CS System, which segments tissue via segmenting wires using RF energy. The device is not intended to provide any therapeutic effect.
All subjects will be followed for safety through two post-procedure follow-up visits. One will be scheduled at a minimum of 14 days and a maximum of 21 days post-operatively. The second will be a follow-up phone call scheduled at a minimum of 30 days and a maximum of 45 days post-operatively.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical | Other | Device: Eximis CS (Contained Segmentation) Systemcontainment, segmentation, and extraction of uterine tissue |
Who may qualify
- Ages
- 21 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Planned laparoscopic hysterectomy or myomectomy. Tissue specimen size is greater than 6 cm in diameter, less than 13 cm in the longest dimension, and at most 10 cm in the second longest dimension, based on 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.
Key exclusion criteria (10 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 Subject has an implanted electronic device where use of radiofrequency (RF) energy would be contraindicated (e.g., pacemaker, internal defibrillator).
- Medical condition, surgical history, or intra-operative findings, which in the option of the investigator, precludes utilization of the Eximis CS System.
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) SystemThe Eximis CS System is an integrated system consisting of a 900 mL Capture Bag, Inflation Mechanism, two Eximis Segmenters, and the Eximis RF Generator. | Device | Surgical |
Primary outcome
Performance
Time frame: 2 months
Percentage of procedures successfully completed with use of the Eximis CS device per the Instructions for Use and without breach of the containment bag.
1 secondary outcome
Usability
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Individual participant dataSharing planned: Undecided
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.
Scott Chudnoff, MD principal investigator
Maimonides Medical Center
4 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 Surgical Procedures, run by Eximis Surgical at 4 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 3 inclusion and 10 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: finished, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Performance (time frame: 2 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 30 Oct 2025; AzTrials last refreshed its copy on 31 Oct 2026.