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

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

Official Title
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Evaluation of Safety and Effectiveness of the FMwand Ferromagnetic Surgical System During Total Mesorectal Excision Surgery

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: Total Mesorectal Excision
* Device: FMwand Surgical System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Total Mesorectal Excision<br>Patients with an indication for surgical intervention for a total mesorectal excision | Procedure: Total Mesorectal Excision<br>* Surgical intervention with the FMwand Surgical System<br>Device: FMwand Surgical System<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Serious Adverse Events as a Measure of Safety and Feasibility | Safety and feasibility will be assessed by evaluating intra-operative serious adverse events, if any, and their relationship with the FMwand Ferromagnetic Surgical System | 1 day after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Drainage | Volume of drainage and drain residence time | Beginning day 2 after surgery and for the duration of the hospital stay, an expected average of 6 days | 
| Onset of urinary or fecal incontinence | Incidence of urinary or fecal incontinence attributed to post-surgical nerve dysfunction | Beginning day 2 after surgery and for the duration of the hospital stay, an expected average of 6 days | 
| Duration of Procedure | Total operative time | During Procedure | 
| Duration of TME resection | Total resection time | During procedure | 
| Evaluation of post-operative complications | Evaluation of pelvic fibrosis, adherences, abscess or fluid collections assessed by CT scan | 12 weeks after surgery |