Clinical trial · Observational
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
NCT02423174CI-TRIAL-00025907withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding
Summary
Brief summary (as posted)
The objective of the clinical trial is to determine the suitability of the FMwand Ferromagnetic Surgical System for Total Mesorectal Excision Surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FMwand Surgical System | Device | — | UNRESOLVED |
| Total Mesorectal Excision | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Total Mesorectal Excision
- description
- Patients with an indication for surgical intervention for a total mesorectal excision
- interventionNames
- Procedure: Total Mesorectal Excision
- Device: FMwand Surgical System
Primary outcomes (1)
- measure
- Intraoperative Serious Adverse Events as a Measure of Safety and Feasibility
- timeFrame
- 1 day after surgery
- description
- 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 (5)
- measure
- Post-operative Drainage
- timeFrame
- Beginning day 2 after surgery and for the duration of the hospital stay, an expected average of 6 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDBowers 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. PMID 24406264
- BACKGROUNDMacDonald 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. PMID 24006128
- BACKGROUNDTok, S et al. Comparison of a Novel Thermal Surgical Technology with Monopolar and Carbon Dioxide Laser in a Rat Glioma Model. Poster presentation.