Low Anterior ResectionNCT01717014

Radial Reload Open LAR Case Series

A study testing Covidien Radial Reload Stapler with Tri-Staple Technology in people with Low Anterior Resection and Proctosigmoid Resection, run by Medtronic - MITG at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this research study is to evaluate the safety and feasibility of the Radial Reload Stapler during open LAR for rectal cancer. The surgeon will complete questionnaires relating to the function of the device. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Low Anterior Resection, Proctosigmoid Resection, Rectal Cancer
What is being tested?: Covidien Radial Reload Stapler with Tri-Staple Technology
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 3 sitesUnited States
Study dates: May 2013to Nov 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The subject is able to understand and sign Informed Consent Form.
The subject is between 18-85 years of age.
The subject is anticipated to undergo a resection of the rectum with anastomosis below the peritoneal reflection for the treatment of rectal cancer.
The subject is anticipated to undergo mobilization and stapling of the rectum through an open incision.

Who cannot join

Any female patient, who is pregnant, suspected pregnant, or nursing.
The participant is unable or unwilling to comply with the study requirements, follow-up schedule.
The participant has co-morbidities which, in the opinion of the investigator, will not be appropriate for the study.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Duke University
Durham, North Carolina, 27705
Providence Medical Center
Spokane, Washington, 99204
University of South Florida
Tampa, Florida, 33606

Other trials in United States

About this study

Official title: Evaluating the Radial Reload Stapler With Tri-Staple TM Technology During Open Low Anterior Resection for Rectal Cancer: A Prospective Multicenter Case Series

Conditions: Low Anterior Resection, Proctosigmoid Resection, Rectal Cancer
Being tested: Covidien Radial Reload Stapler with Tri-Staple Technology
Keywords: rectal cancer, stapler
Medical subject headings: Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Covidien Radial Reload Stapler with Tri-Staple TechnologyDevice
Case series of patients already selected to undergo an open LAR or proctosigmoidectomy using the Radial Reload Stapler

Study groups in NCT01717014
Study group	Role	What they receive
Covidien Radial Reload Stapler with Tri-Staple Technology	Experimental	Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy Receives: Device: Covidien Radial Reload Stapler with Tri-Staple Technology

What is being measured

The primary outcome is the main question the study is designed to answer.

Staple Line
The surgeons ability to achieve a staple line at the desired level of the rectum.
Measured: Operative
Distal Margins
The ability to achieve adequate distal margins (defined as >2cm [or >1cm with clear histologic evaluation]) in the low rectum.
Measured: Operative

Secondary outcomes (3)

Usability: Visibility
Visibility measured by surgeon usability questionnaire.
Measured: Operatively
Usability: Access
Access measured by surgeon usability questionnaire
Measured: Operatively
Usability: Manueverability
Manueverability measured by surgeon usability questionnaire. Question: Maneuverability of Radial reload during the procedure was adequate
Measured: Operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013Nov 2013

First posted30 Oct 2012 (estimated)
Study startMay 2013
Primary completionNov 2013
Study completionNov 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Low Anterior ResectionStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01717014
Sponsor's protocol ID: COVLARO0286
Status last verified: Feb 2015
First submitted: 26 Oct 2012
Last updated: 2 Mar 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Recruiting
A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients
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RecruitingPhase 2
Local Methylene Blue Injection for Prevention of Anastomotic Leakage and Permanent Stoma After Low Anterior Resection for Rectal Cancer
Rectal Cancers
Recruiting
Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections
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Recruiting
PARLAR-02 Trial：Modified Transanal Drainage Tube Use for Preventing Anastomotic Leakage
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All Low Anterior Resection trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Radial Reload Stapler With Tri-Staple TM Technology During Open Low Anterior Resection for Rectal Cancer: A Prospective Multicenter Case Series
ClinicalTrials.gov ID: NCT01717014
Acronym / sponsor ID: COVLARO0286
Conditions: Low Anterior Resection, Proctosigmoid Resection, Rectal Cancer
Keywords: rectal cancer, stapler
Study type: Interventional
Recruitment status: Terminated
Enrolment: 8 participants (actual)
Lead sponsor: Medtronic - MITGIndustry (pharma, biotech, devices)
Collaborators: Duke University, Providence Medical Research Center, University of South Florida
Study start: May 2013
Primary completion: Nov 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 30 Oct 2012 (estimated)
Results: Posted 2 Mar 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Covidien Radial Reload Stapler with Tri-Staple Technology	Experimental	Device: Covidien Radial Reload Stapler with Tri-Staple TechnologyCovidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

The subject is able to understand and sign Informed Consent Form.
The subject is between 18-85 years of age.
The subject is anticipated to undergo a resection of the rectum with anastomosis below the peritoneal reflection for the treatment of rectal cancer.
The subject is anticipated to undergo mobilization and stapling of the rectum through an open incision.

Key exclusion criteria (3 listed)

Any female patient, who is pregnant, suspected pregnant, or nursing.
The participant is unable or unwilling to comply with the study requirements, follow-up schedule.
The participant has co-morbidities which, in the opinion of the investigator, will not be appropriate for the study.

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
Covidien Radial Reload Stapler with Tri-Staple TechnologyCase series of patients already selected to undergo an open LAR or proctosigmoidectomy using the Radial Reload Stapler	Device	Covidien Radial Reload Stapler with Tri-Staple Technology

Primary outcome

Staple Line
Time frame: Operative
The surgeons ability to achieve a staple line at the desired level of the rectum.
Distal Margins
Time frame: Operative
The ability to achieve adequate distal margins (defined as >2cm [or >1cm with clear histologic evaluation]) in the low rectum.

3 secondary outcomes

Usability: Visibility
Time frame: Operatively
Usability: Access
Time frame: Operatively
Usability: Manueverability
Time frame: Operatively

Results and safety

Results posted to the registry on 2 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Covidien Radial Reload Stapler With Tri-Staple Technology	8	8

Primary outcome: Staple Line

Time frame: Operative. Number. Unit: participants

Measure	Covidien Radial Reload Stapler With Tri-Staple Technology n = 8
Value	7

Primary outcome: Distal Margins

Time frame: Operative. Number. Unit: participants

Measure	Covidien Radial Reload Stapler With Tri-Staple Technology n = 8
Value	8

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected through the 30 day follow-up visit. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Covidien Radial Reload Stapler With Tri-Staple Technology	4 of 8 (50%)	2 of 8 (25%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Low Anterior Resection

Not yet recruiting
Efficacy of a Novel High Intensive Percutaneous Tibial Nerve Stimulation on Faecal Incontinence in Patients With Low Anterior Resection Cancer Syndrome After Rectal Cancer Surgery
Faecal Incontinence With Faecal Urgency, Rectal Cancer
Recruiting
A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients
Low Anterior Resection Syndrome, Rectal Carcinoma
RecruitingPhase 2
Local Methylene Blue Injection for Prevention of Anastomotic Leakage and Permanent Stoma After Low Anterior Resection for Rectal Cancer
Rectal Cancers
Recruiting
Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections
Colorectal Anastomosis, Left-sided Colon Resection
Recruiting
PARLAR-02 Trial：Modified Transanal Drainage Tube Use for Preventing Anastomotic Leakage
Anastomotic Leak

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.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Covidien Radial Reload Stapler with Tri-Staple Technology in people with Low Anterior Resection and Proctosigmoid Resection, run by Medtronic - MITG at 3 sites in United States.

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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 2 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 2 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Staple Line (time frame: Operative). The study lists 2 primary outcomes in all. 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 NCT01717014.

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 2 Mar 2015.