Eximis CS System for Keyhole Surgery

No longer recruiting at 3 trial locations

Overseen By Hilary A Baldwin

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Eximis Surgical

Disqualifiers: Post-menopausal, Malignancy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Surgical procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Eximis CS System, a device designed to assist with keyhole surgeries such as laparoscopic hysterectomies or myomectomies. The trial aims to evaluate the device's safety and effectiveness in containing, cutting, and removing uterine tissue. Individuals planning to undergo one of these surgeries, with a tissue size between 6 and 13 cm, might be suitable candidates. Participants must complete specific pre-surgery tests and agree to follow the study's guidelines. As an unphased trial, this study allows participants to contribute to innovative surgical advancements.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.

What prior data suggests that the Eximis CS System is safe for keyhole surgery?

Research has shown that the Eximis CS System, used for minimally invasive surgery, has undergone safety testing. It employs small incisions and includes safety features such as three specially designed bags to contain, separate, and remove uterine tissue securely. These features help maintain control and prevent complications during surgery.

Although specific details about side effects are not available, the emphasis on safety features suggests that the Eximis CS System prioritizes safety. Ongoing research continues to evaluate its safety and effectiveness, indicating that any major safety issues would have been addressed before reaching this stage. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Eximis CS System is unique because it introduces a minimally invasive technique for the containment, segmentation, and extraction of uterine tissue. Unlike traditional surgical options, which often involve larger incisions and longer recovery times, this keyhole surgery approach aims to reduce patient recovery time and minimize surgical risks. Researchers are excited about this system because it could offer a safer and more efficient alternative to current surgical methods, potentially improving outcomes and comfort for patients undergoing uterine surgery.

What evidence suggests that the Eximis CS System is effective for keyhole surgery?

Research shows that the Eximis CS System, used by participants in this trial, is designed to keep surgical cuts small. This design reduces infection risk and may lead to less pain and quicker recovery. The system safely removes tissue during minimally invasive surgery. Although direct data on its effectiveness is still being collected, the design aims to make surgeries safer and recovery faster. It focuses on improving patient outcomes by reducing complications associated with larger cuts. ^{1 2 3 5 6}

Who Is on the Research Team?

Scott Chudnoff, MD

Principal Investigator

Maimonides Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals scheduled for keyhole surgery, specifically a laparoscopic hysterectomy or myomectomy. Participants must have completed pre-operative evaluations and consent to follow the study's procedures. They should have tissue specimens larger than 6 cm but not exceeding 13 cm in length.

Inclusion Criteria

I have completed all required tests before surgery, including imaging and cancer screenings.

I have signed the consent form and agree to follow the study rules.

I am scheduled for a laparoscopic surgery to remove my uterus or fibroids, and the tissue to be removed meets specific size requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo laparoscopic hysterectomy or myomectomy using the Eximis CS System for containment, segmentation, and extraction of uterine tissue

Surgical procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

4-6 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Eximis CS (Contained Segmentation) System

Trial Overview The Eximis CS System, a device used during keyhole surgeries like hysterectomies and myomectomies, is being tested for safety and effectiveness. The study will monitor outcomes of those using this system.

How Is the Trial Designed?

Group I: Surgical Experimental Treatment 1 Intervention

containment, segmentation, and extraction of uterine tissue

Who Is Running the Clinical Trial?

Eximis Surgical

Lead Sponsor

Trials

2

Recruited

30+

Proxima Clinical Research

Collaborator

Trials

3

Recruited

580+

Proxima CRO

Industry Sponsor

Trials

5

Recruited

830+

Published Research Related to This Trial

Computer-assisted surgery (CAS) technology enhances the safety and efficiency of minimally invasive procedures for treating conditions like tumors and inflammatory diseases in the anterior and lateral skull base, as demonstrated by accuracy tests showing a mean error of 0.79 mm on cadaver skulls.

The integration of CAS systems with microscopes and new noninvasive registration methods allows for precise navigation during surgery, with clinical accuracy ranging from 0.5 mm to 2 mm, supporting better outcomes in surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Present state and future perspectives of computer aided surgery in the field of ENT and skull base. Caversaccio, M., Nolte, LP., Häusler, R.[2016]

The Surgix computer-assisted surgery system significantly improved the success rate of guide wire insertion in dynamic hip screw procedures, achieving a first-trial success rate of 77.8% compared to only 10% in the control group.

Using Surgix also reduced the number of fluoroscopy pulses by 41.5%, which lowers radiation exposure for patients, while maintaining accuracy in hardware positioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-assisted surgery for dynamic hip screw, using Surgix, a novel intraoperative guiding system. Herman, A., Dekel, A., Botser, IB., et al.[2016]

The Dextroscope virtual reality system significantly enhances pre-operative surgical planning for meningioma resections by providing detailed 3D visualizations of tumors and their relationships with critical brain structures and blood vessels.

In a study involving 30 patients with different types of meningiomas, the use of this system allowed for effective simulation of surgical procedures, leading to successful real-life operations and improved patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative surgical planning for intracranial meningioma resection by virtual reality. Tang, HL., Sun, HP., Gong, Y., et al.[2016]

The Synaptive Modus V exoscope system demonstrated better visual quality and greater comfort for surgeons compared to traditional microscopes during eight neurosurgical procedures, including both spinal and cranial surgeries.

While the exoscope provided superior image quality, it offered slightly less depth perception, suggesting that while it is a safe and effective tool, surgeons may benefit from additional training before using it in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary experience with a digital robotic exoscope in cranial and spinal surgery: a review of the Synaptive Modus V system. Muhammad, S., Lehecka, M., Niemelä, M.[2020]

Computer-integrated surgery and therapy (CIST) utilizes multimodal data, primarily medical images, to enhance the planning and execution of medical interventions.

CIST employs various guiding systems—passive, semi-active, or active—to assist surgeons and physicians in making more informed and precise decisions during procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An overview of computer-integrated surgery and therapy. Lavallée, S., Bainville, E., Bricault, I.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06572163

NCT06572163 | Clinical Validation Study of the Eximis CS ... This is a prospective, multi-center, single-arm study to confirm device safety and effectiveness when utilized for containment, segmentation, and extraction of ...

2. eximissurgical.com eximissurgical.com/solution/

our solution - contained specimen segmentation and removal Designed to keep incisions small throughout the procedure and provide fast, fully contained specimen segmentation and removal, The Eximis Lap Specimen Removal ...

3. clinconnect.io clinconnect.io/trials/NCT06572163

Clinical Validation Study of the Eximis CS (Contained This clinical trial is studying a new device called the Eximis CS System, which is being tested for safety and effectiveness during laparoscopic gynecological ...

4. eximissurgical.com eximissurgical.com/need/

Eximis Surgical | An Opportunity with Huge Potential Designed to keep incisions small throughout the procedure and provide fast, fully contained specimen segmentation and removal.

5. olympusamerica.com olympusamerica.com/blog/medical-technologies/when-little-things-are-big-deal-olympus-investment-eximis-aims-keep

Olympus' Investment in Eximis Aims to Keep Incisions Small Smaller incisions are intended to benefit the patient by lowering the risk of infection, with the potential for less pain, faster recovery, and reduced hospital ...

6. cms.gov cms.gov/httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200318-nct04799210

G200318-NCT04799210 Study Title: Human Factors Actual-Use Confirmatory Validation Study of the Eximis CS (Contained Segmentation) System ("Contain" Study)