Clinical trial NCT02423174: Eval. of Safety and Effectiveness of the FMwand Ferromagnetic Surgical System During Total Mesorectal Excision Surgery
Official title: Evaluation of Safety and Effectiveness of the FMwand Ferromagnetic Surgical System During Total Mesorectal Excision Surgery
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Colorectal Cancer
Lead sponsor: Domain Surgical, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an indication for surgical intervention for a total mesorectal excision

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


Eligibility criteria: 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

Primary outcomes:
measure: Intraoperative Serious Adverse Events as a Measure of Safety and Feasibility
timeFrame: 1 day after surgery
Secondary outcomes:
measure: Post-operative Drainage
timeFrame: Beginning day 2 after surgery and for the duration of the hospital stay, an expected average of 6 days
measure: Onset of urinary or fecal incontinence
timeFrame: Beginning day 2 after surgery and for the duration of the hospital stay, an expected average of 6 days
measure: Duration of Procedure
timeFrame: During Procedure
measure: Duration of TME resection
timeFrame: During procedure
measure: Evaluation of post-operative complications
timeFrame: 12 weeks after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Istituto Nationale Tumori IRCCS - Fondazione "G Pascale"
name: Francesco Izzo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Tok, S et al. Comparison of a Novel Thermal Surgical Technology with Monopolar and Carbon Dioxide Laser in a Rat Glioma Model. Poster presentation.