Eval. of Safety and Effectiveness of the FMwand Ferromagnetic Surgical System During Total Mesorectal Excision Surgery
Study Details
Study Description
Brief Summary
The objective of the clinical trial is to determine the suitability of the FMwand Ferromagnetic Surgical System for Total Mesorectal Excision Surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Total Mesorectal Excision Patients with an indication for surgical intervention for a total mesorectal excision |
Procedure: Total Mesorectal Excision
Surgical intervention with the FMwand Surgical System
Device: FMwand Surgical System
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Confirmed rectal cancer to the lower two-thirds of the rectum (higher and T2 N0 or N+)
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Amenable for standard surgery procedures using electrocautery, argon beam, lasers or other conventional tissue removal modalities
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ECOG status ≤ 2
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Life expectancy >3 months
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Age ≥ 18 years old
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Age ≤ 80 years old
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Ability to provide written informed consent and HIPAA forms prior to admission to this study
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Willingness to meet all of the expected requirements of this clinical protocol
Exclusion Criteria:
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Patient with metastasis
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History of radiotherapy or chemotherapy for the treatment of rectal cancer
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Uremia - BUN>40
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Hemodialysis
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Existing urinary or fecal incontinence
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Pregnant or lactating
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Previously diagnosed coagulopathy or bleeding diathesis
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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
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History of significant cardiac disorders that would necessitate special fluid management protocols
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History of acute myocardial infarction and/or acute angina
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INR >1.4 in the 24 hours prior to surgery
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PTT >40 in the 24 hours prior to surgery
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Platelet count <100K in the 24 hours prior to surgery
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Domain Surgical, Inc.
Investigators
- Principal Investigator: Francesco Izzo, MD, Istituto Nationale Tumori IRCCS - Fondazione "G Pascale"
Study Documents (Full-Text)
None provided.More Information
Publications
- Bowers CA, Burns G, Salzman KL, McGill LD, Macdonald JD. Comparison of tissue effects in rabbit muscle of surgical dissection devices. Int J Surg. 2014;12(3):219-23. doi: 10.1016/j.ijsu.2013.12.014. Epub 2014 Jan 7.
- MacDonald JD, Bowers CA, Chin SS, Burns G. Comparison of the effects of surgical dissection devices on the rabbit liver. Surg Today. 2014 Jun;44(6):1116-22. doi: 10.1007/s00595-013-0712-4. Epub 2013 Sep 5.
- Tok, S et al. Comparison of a Novel Thermal Surgical Technology with Monopolar and Carbon Dioxide Laser in a Rat Glioma Model. Poster presentation.
- FMW-IT-02