Eval. of Safety and Effectiveness of the FMwand Ferromagnetic Surgical System During Total Mesorectal Excision Surgery
NCT ID: NCT02423174
Last Updated: 2017-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2016-01-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Total Mesorectal Excision
Patients with an indication for surgical intervention for a total mesorectal excision
Total Mesorectal Excision
Surgical intervention with the FMwand Surgical System
FMwand Surgical System
Interventions
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Total Mesorectal Excision
Surgical intervention with the FMwand Surgical System
FMwand Surgical System
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Domain Surgical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Francesco Izzo, MD
Role: PRINCIPAL_INVESTIGATOR
Istituto Nationale Tumori IRCCS - Fondazione "G Pascale"
References
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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.
Other Identifiers
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FMW-IT-02
Identifier Type: -
Identifier Source: org_study_id
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