Eximis CS System for Keyhole Surgery

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

30 Participants Needed

Trial Summary

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.

How is the Eximis CS System treatment different from other treatments for keyhole surgery?

The Eximis CS System is unique because it integrates computer-assisted technology to enhance the precision and safety of keyhole surgeries, allowing surgeons to measure distances and visualize the surgical area in 3D, which is not typically available in standard procedures. ^{1 2 3 4 5}

What is the purpose of this trial?

The purpose of this study is to evaluate device safety and effectiveness of the Eximis CS System.

Research Team

Scott Chudnoff, MD

Principal Investigator

Maimonides Medical Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. China pubmed.ncbi.nlm.nih.gov

Preoperative surgical planning for intracranial meningioma resection by virtual reality. [2016]

2. Austria 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. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

An overview of computer-integrated surgery and therapy. [2019]

4. Belgium pubmed.ncbi.nlm.nih.gov

Present state and future perspectives of computer aided surgery in the field of ENT and skull base. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Computer-assisted surgery for dynamic hip screw, using Surgix, a novel intraoperative guiding system. [2016]