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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: Total Mesorectal Excision; Device: FMwand Surgical System

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with an indication for surgical intervention for a total mesorectal excision

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Serious Adverse Events as a Measure of Safety and Feasibility	Safety and feasibility will be assessed by evaluating intra-operative serious adverse events, if any, and their relationship with the FMwand Ferromagnetic Surgical System	1 day after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative Drainage	Volume of drainage and drain residence time	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	Incidence of urinary or fecal incontinence attributed to post-surgical nerve dysfunction	Beginning day 2 after surgery and for the duration of the hospital stay, an expected average of 6 days
Duration of Procedure	Total operative time	During Procedure
Duration of TME resection	Total resection time	During procedure
Evaluation of post-operative complications	Evaluation of pelvic fibrosis, adherences, abscess or fluid collections assessed by CT scan	12 weeks after surgery

Collaborators and Investigators

• Sponsor: Domain Surgical, Inc.
• Investigators: Principal Investigator: Francesco Izzo, MD, Istituto Nationale Tumori IRCCS - Fondazione "G Pascale"

Publications and helpful links

General 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.
• Tok, S et al. Comparison of a Novel Thermal Surgical Technology with Monopolar and Carbon Dioxide Laser in a Rat Glioma Model. Poster presentation.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: April 17, 2015
• First Submitted That Met QC Criteria: April 21, 2015
• First Posted (Estimate): April 22, 2015

Study Record Updates

• Last Update Posted (Actual): February 10, 2017
• Last Update Submitted That Met QC Criteria: February 9, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: FMW-IT-02