Colorectal Cancer
Conditions
Brief summary
The objective of the clinical trial is to determine the suitability of the FMwand Ferromagnetic Surgical System for Total Mesorectal Excision Surgery.
Interventions
PROCEDURETotal Mesorectal Excision
Surgical intervention with the FMwand Surgical System
DEVICEFMwand Surgical System
Sponsors
Domain Surgical, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Serious Adverse Events as a Measure of Safety and Feasibility | 1 day after surgery | Safety and feasibility will be assessed by evaluating intra-operative serious adverse events, if any, and their relationship with the FMwand Ferromagnetic Surgical System |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Drainage | Beginning day 2 after surgery and for the duration of the hospital stay, an expected average of 6 days | Volume of drainage and drain residence time |
| Onset of urinary or fecal incontinence | Beginning day 2 after surgery and for the duration of the hospital stay, an expected average of 6 days | Incidence of urinary or fecal incontinence attributed to post-surgical nerve dysfunction |
| Duration of Procedure | During Procedure | Total operative time |
| Duration of TME resection | During procedure | Total resection time |
| Evaluation of post-operative complications | 12 weeks after surgery | Evaluation of pelvic fibrosis, adherences, abscess or fluid collections assessed by CT scan |
Outcome results
None listed