Colorectal CancerNCT02423174
Eval. of Safety and Effectiveness of the FMwand Ferromagnetic Surgical System During Total Mesorectal Excision Surgery
An observational study of Colorectal Cancer, run by Domain Surgical, Inc..
Trial summary
The objective of the clinical trial is to determine the suitability of the FMwand Ferromagnetic Surgical System for Total Mesorectal Excision Surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Total Mesorectal Excision and FMwand Surgical System
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an indication for surgical intervention for a total mesorectal excision
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
About this study
Official title: 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.
- Conditions
- Colorectal Cancer
- Being tested
- Total Mesorectal Excision, FMwand Surgical System
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Mesorectal ExcisionProcedure or surgery
Surgical intervention with the FMwand Surgical System
FMwand Surgical SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Total Mesorectal Excision | Patients with an indication for surgical intervention for a total mesorectal excision Receives: Procedure: Total Mesorectal Excision; Device: FMwand Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day after surgery
Secondary outcomes (5)
Post-operative Drainage
Volume of drainage and drain residence time
Measured: 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
Measured: 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
Measured: During Procedure
Duration of TME resection
Total resection time
Measured: During procedure
Evaluation of post-operative complications
Evaluation of pelvic fibrosis, adherences, abscess or fluid collections assessed by CT scan
Measured: 12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Domain Surgical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francesco Izzo, MD, Principal investigator, Istituto Nationale Tumori IRCCS - Fondazione "G Pascale"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423174
- Sponsor's protocol ID
- FMW-IT-02
- Status last verified
- Feb 2017
- First submitted
- 17 Apr 2015
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24406264MacDonald 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.
PubMed 24006128Tok, S et al. Comparison of a Novel Thermal Surgical Technology with Monopolar and Carbon Dioxide Laser in a Rat Glioma Model. Poster presentation.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Effectiveness of the FMwand Ferromagnetic Surgical System During Total Mesorectal Excision Surgery
- ClinicalTrials.gov ID
- NCT02423174
- Acronym / sponsor ID
- FMW-IT-02
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Domain Surgical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 22 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the clinical trial is to determine the suitability of the FMwand Ferromagnetic Surgical System for Total Mesorectal Excision Surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total Mesorectal Excision | – | Procedure: Total Mesorectal Excision, Device: FMwand Surgical SystemPatients with an indication for surgical intervention for a total mesorectal excision |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an indication for surgical intervention for a total mesorectal excision
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- Patient with metastasis
- History of radiotherapy or chemotherapy for the treatment of rectal cancer
- Uremia - BUN>40
- Hemodialysis
- Existing urinary or fecal incontinence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Mesorectal ExcisionSurgical intervention with the FMwand Surgical System | Procedure or surgery | Total Mesorectal Excision |
| FMwand Surgical System | Device | Total Mesorectal Excision |
Primary outcome
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
5 secondary outcomes
Post-operative Drainage
Time frame: 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
Time frame: Beginning day 2 after surgery and for the duration of the hospital stay, an expected average of 6 days
Duration of Procedure
Time frame: During Procedure
Duration of TME resection
Time frame: During procedure
Evaluation of post-operative complications
Time frame: 12 weeks after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Background: PubMed 24406264Bowers 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.
- Background: PubMed 24006128MacDonald 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.
- BackgroundTok, S et al. Comparison of a Novel Thermal Surgical Technology with Monopolar and Carbon Dioxide Laser in a Rat Glioma Model. Poster presentation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Izzo, MD principal investigator
Istituto Nationale Tumori IRCCS - Fondazione "G Pascale"
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Domain Surgical, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Serious Adverse Events as a Measure of Safety and Feasibility (time frame: 1 day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02423174, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2017.