Eval. of Safety and Effectiveness of the FMwand Ferromagnetic Surgical System During Total Mesorectal Excision Surgery

Domain Surgical

Status: Withdrawn

Conditions: Colorectal Cancer

Treatments: Procedure: Total Mesorectal Excision; Device: FMwand Surgical System

Study type: Observational

Funder types: Industry

Identifiers

NCT02423174

FMW-IT-02

Details and patient eligibility

About

The objective of the clinical trial is to determine the suitability of the FMwand Ferromagnetic Surgical System for Total Mesorectal Excision Surgery.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed rectal cancer to the lower two-thirds of the rectum (higher and T2 N0 or N+)
• Amenable for standard surgery procedures using electrocautery, argon beam, lasers or other conventional tissue removal modalities
• ECOG status ≤ 2
• Life expectancy >3 months
• Age ≥ 18 years old
• Age ≤ 80 years old
• Ability to provide written informed consent and HIPAA forms prior to admission to this study
• Willingness to meet all of the expected requirements of this clinical protocol

Exclusion criteria

• Patient with metastasis
• History of radiotherapy or chemotherapy for the treatment of rectal cancer
• Uremia - BUN>40
• Hemodialysis
• Existing urinary or fecal incontinence
• Pregnant or lactating
• Previously diagnosed coagulopathy or bleeding diathesis
• Currently, or within the previous 10 days prior to surgery, taking any medications that would produce bleeding diathesis including but not limited to, Plavix, warfarin, NSAIDs, clopidogrel, ticlopidine or valproic acid
• History of significant cardiac disorders that would necessitate special fluid management protocols
• History of acute myocardial infarction and/or acute angina
• INR >1.4 in the 24 hours prior to surgery
• PTT >40 in the 24 hours prior to surgery
• Platelet count <100K in the 24 hours prior to surgery

Trial design

0 participants in 1 patient group

Total Mesorectal Excision

Description:

Patients with an indication for surgical intervention for a total mesorectal excision

Treatment:

Procedure: Total Mesorectal Excision

Device: FMwand Surgical System