Eval. of Safety and Effectiveness of the FMwand Ferromagnetic Surgical System During Total Mesorectal Excision Surgery

Withdrawn

• Conditions: Colorectal Cancer
• Interventions: Procedure: Total Mesorectal Excision; Device: FMwand Surgical System

• Registration Number: NCT02423174
• Lead Sponsor: Domain Surgical, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-17
• Study First Submitted QC: 2015-04-21
• Study First Posted: 2015-04-22
• Study Start: 2016-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-10
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Total Mesorectal Excision	Total Mesorectal Excision	Patients with an indication for surgical intervention for a total mesorectal excision
Total Mesorectal Excision	FMwand Surgical System	Patients with an indication for surgical intervention for a total mesorectal excision

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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