NCT02423174WithdrawnNot Applicable
Evaluation of Safety and Effectiveness of the FMwand Ferromagnetic Surgical System During Total Mesorectal Excision Surgery
Domain Surgical, Inc.0 sitesStarted: January 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Primary Endpoint
- Intraoperative Serious Adverse Events as a Measure of Safety and Feasibility
Study Overview
Brief Summary
The objective of the clinical trial is to determine the suitability of the FMwand Ferromagnetic Surgical System for Total Mesorectal Excision Surgery.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Intraoperative Serious Adverse Events as a Measure of Safety and Feasibility
Time Frame: 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 Outcomes
- Post-operative Drainage(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(Beginning day 2 after surgery and for the duration of the hospital stay, an expected average of 6 days)
- Duration of Procedure(During Procedure)
- Duration of TME resection(During procedure)
- Evaluation of post-operative complications(12 weeks after surgery)
Investigators
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