Colorectal CancerPhase 4NCT01706822

Radial Reload Laparoscopic LAR Case Series

A Phase 4 study testing Covidien Radial Reload Stapler with Tri-Staple Technology in people with Colorectal Cancer, run by Medtronic - MITG at 1 site 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

To evaluate the Radial Reload Stapler during laparoscopic low anterior resection (LAR) or anterior proctosigmoidectomy for rectal cancer by assessing the primary and secondary endpoints. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Colorectal 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: 1 siteUnited States
Study dates: Apr 2013to Nov 2013
Phase: Phase 4
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.
The subject is anticipated to undergo mobilization and stapling of the rectum laparoscopically.

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

1 site in 1 country.

United States1 site

University Hospitals Case Medical Center
Cleveland, Ohio, 44106

Other trials in United States

About this study

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

To evaluate the Radial Reload Stapler during laparoscopic low anterior resection (LAR) or anterior proctosigmoidectomy for rectal cancer by assessing the primary and secondary endpoints.

Conditions: Colorectal Cancer
Being tested: Covidien Radial Reload Stapler with Tri-Staple Technology
Medical subject headings: Colorectal 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 arlaedy selected to undergo a laparoscopic LAR using the Radial Reload stapler

Study groups in NCT01706822
Study group	Role	What they receive
Covidien Radial Reload Stapler with Tri-Staple Technology	Experimental	Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic LAR or 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.

The Surgeon's Ability to Achieve a Staple Line at the Desired Level of the Rectum. The Reported Value Represents the Number of Participants in Whom the Criteria Was Met
The surgeon's ability to achieve a staple line at the desired level of the rectum.
Measured: Operative
The Ability to Achieve Adequate Distal Margins (Defined as >2cm [or >1cm With Clear Histologic Evaluation]) in the Low Rectum. The Reported Value Represents the Number of Participants in Whom the Criteria Was Met
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)

Access Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree
1. Access measured by surgeon usability questionnaire.
Measured: Operatively
Visibility Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree
1. Visibility measured by surgeon usability questionnaire
Measured: Operatively
Maneuverability Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree
1. Maneuverability 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.

Apr 2013Nov 2013

First posted15 Oct 2012 (estimated)
Study startApr 2013
Primary completionNov 2013
Study completionNov 2013

Why it stopped: Slow recruitment

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 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: Interventional
Phase: Phase 4
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: NCT01706822
Sponsor's protocol ID: COVLARL0287
Status last verified: Mar 2015
First submitted: 11 Oct 2012
Last updated: 18 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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Study at a glance

From the registry record, last updated by the sponsor on 18 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 Laparoscopic Low Anterior Resection for Rectal Cancer: A Prospective Multicenter Case Series
ClinicalTrials.gov ID: NCT01706822
Acronym / sponsor ID: COVLARL0287
Conditions: Colorectal Cancer
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Slow recruitment
Enrolment: 8 participants (actual)
Lead sponsor: Medtronic - MITGIndustry (pharma, biotech, devices)
Collaborators: University Hospitals Cleveland Medical Center, Duke University
Study start: Apr 2013
Primary completion: Nov 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 15 Oct 2012 (estimated)
Results: Posted 18 Mar 2015

Clinical summary

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

To evaluate the Radial Reload Stapler during laparoscopic low anterior resection (LAR) or anterior proctosigmoidectomy for rectal cancer by assessing the primary and secondary endpoints.

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 laparoscopic LAR or 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.
The subject is anticipated to undergo mobilization and stapling of the rectum laparoscopically.

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 arlaedy selected to undergo a laparoscopic LAR using the Radial Reload stapler	Device	Covidien Radial Reload Stapler with Tri-Staple Technology

Primary outcome

The Surgeon's Ability to Achieve a Staple Line at the Desired Level of the Rectum. The Reported Value Represents the Number of Participants in Whom the Criteria Was Met
Time frame: Operative
The surgeon's ability to achieve a staple line at the desired level of the rectum.
The Ability to Achieve Adequate Distal Margins (Defined as >2cm [or >1cm With Clear Histologic Evaluation]) in the Low Rectum. The Reported Value Represents the Number of Participants in Whom the Criteria Was Met
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

Access Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree
Time frame: Operatively
Visibility Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree
Time frame: Operatively
Maneuverability Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree
Time frame: Operatively

Results and safety

Results posted to the registry on 18 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: The Surgeon's Ability to Achieve a Staple Line at the Desired Level of the Rectum. The Reported Value Represents the Number of Participants in Whom the Criteria Was Met

Time frame: Operative. Number. Unit: participants

Measure	Covidien Radial Reload Stapler With Tri-Staple Technology n = 8
Value	6

Primary outcome: The Ability to Achieve Adequate Distal Margins (Defined as >2cm [or >1cm With Clear Histologic Evaluation]) in the Low Rectum. The Reported Value Represents the Number of Participants in Whom the Criteria Was Met

Time frame: Operative. Number. Unit: participants

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

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 18 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Conor Delaney, MD principal investigator

University Hospitals Cleveland Medical Center

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Covidien Radial Reload Stapler with Tri-Staple Technology in people with Colorectal Cancer, run by Medtronic - MITG at 1 site 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 18 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 1 site 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 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?

The Surgeon's Ability to Achieve a Staple Line at the Desired Level of the Rectum. The Reported Value Represents the Number of Participants in Whom the Criteria Was Met (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 NCT01706822.

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 18 Mar 2015.