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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02423174
• Other study ID #: FMW-IT-02
• Status: Withdrawn
• Phase: N/A
• First received: April 17, 2015
• Last updated: February 9, 2017
• Start date: January 2016
• Est. completion date: December 2017

Study information

• Verified date: February 2017
• Source: Domain Surgical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• Total Mesorectal Excision
Surgical intervention with the FMwand Surgical System

Device:
• FMwand Surgical System

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Domain Surgical, Inc.

References & Publications (3)

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. — View 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. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Duration of Procedure	Total operative time	During Procedure
Secondary	Duration of TME resection	Total resection time	During procedure
Secondary	Evaluation of post-operative complications	Evaluation of pelvic fibrosis, adherences, abscess or fluid collections assessed by CT scan	12 weeks after surgery