Clinical trial NCT06572163: Clinical Validation Study of the Eximis CS (Contained Segmentation) System
Official title: Clinical Validation Study of the Eximis CS (Contained Segmentation) System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laparoscopic Gynecological Surgical Procedures
Lead sponsor: Eximis Surgical
Sponsor class: INDUSTRY
Collaborators: name: Proxima CRO
First posted: 2024-08-27
Enrollment: 30
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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 a post-procedure follow-up visit that will occur at minimum 30 days and maximum 45 days post-operatively through the post-procedure follow-up visit.

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Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

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.

Primary outcomes:
measure: Performance
timeFrame: 2 months
Secondary outcomes:
measure: Usability
timeFrame: 2 months
Other outcomes:
measure: Adverse Events
timeFrame: 2 months
Locations:
city: Celebration
country: United States
facility: Advent Health, 410 Celebration Place
state: Florida
city: Idaho Falls
country: United States
facility: Rosemark Womens Care Specialists
state: Idaho
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: Portland
country: United States
facility: Oregon Health and Science University School of Medicine
state: Oregon
Study officials:
affiliation: Maimonides Medical Center
name: Scott Chudnoff, MD
role: PRINCIPAL_INVESTIGATOR
References: