ThoracicPhase 4MET1NCT01476761
MicroCutter in Surgical Stapling - European Trial I
A Phase 4 study testing Microcutter XPRESS and Microcutter XCHANGE in people with Thoracic, run by Cardica, Inc at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate safety of the Microcutter stapling /cutting device in patients requiring the transection, resection or anastomosis of gastrointestinal tissue in a post-market approval study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thoracic
- What is being tested?
- Microcutter XPRESS and Microcutter XCHANGE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2011to Jul 2013
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients requiring surgical treatment where the use of a surgical stapler is anticipated
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Cardica MicroCutter in Surgical Stapling: A Prospective, Open-label, Multi-center Study
The purpose of this study is to evaluate safety of the Microcutter stapling /cutting device in patients requiring the transection, resection or anastomosis of gastrointestinal tissue in a post-market approval study.
Read the detailed description
A prospective, open label, multi-center non-inferiority safety study with an all-comers enrollment of patients requiring surgical stapling of the stomach and/or intestine according to the labeled indications contained in the approved labeling. Up to 178 subjects consented for a 1-month clinical follow-up evaluation will be enrolled. Primary endpoint is to statistical non-inferiority of composite major adverse event rate (composite of infection (non-dermal), dehiscence, bleeding, and strictures) in study patients when compared to composite major adverse event rate (composite of infection (non-dermal), dehiscence, bleeding, and strictures) as derived from a comprehensive analysis of the medical literature. The comparison will be performed for cumulative events up to 30 days postoperatively.
- Conditions
- Thoracic
- Being tested
- Microcutter XPRESS and Microcutter XCHANGE
- Keywords
- Surgical tissue resection, Tissue dissection, Tissue transection, Anastomosis of gastrointestina tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microcutter XPRESS and Microcutter XCHANGEDevice
Also called MicroCutter XPRESS30, MicroCutter XPRESS45, MicroCutter XCHANGE30
Surgical stapling devices
| Study group | Role | What they receive |
|---|---|---|
| MicroCutter Stapling Device | Active comparator | Patients undergoing surgical treatment with the MicroCutter Stapling Device Receives: Device: Microcutter XPRESS and Microcutter XCHANGE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite adverse event rate
Composite event rate is a compilation of the following stapling related adverse event rates: bleeding, leakage, stricture and infection
Measured: up to 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThoracicStudies 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardica, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andreas Kithe, M.D., Principal investigator, DRK-Krankenhaus Clementinenhaud, Hannover
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476761
- Sponsor's protocol ID
- CP 2011-01
- Acronym
- MET1
- Status last verified
- Aug 2013
- First submitted
- 18 Nov 2011
- Last updated
- 9 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cardica MicroCutter in Surgical Stapling: A Prospective, Open-label, Multi-center Study
- ClinicalTrials.gov ID
- NCT01476761
- Acronym / sponsor ID
- MET1 / CP 2011-01
- Conditions
- Thoracic
- Keywords
- Surgical tissue resection, Tissue dissection, Tissue transection, Anastomosis of gastrointestina tissue
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Cardica, IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 22 Nov 2011 (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 purpose of this study is to evaluate safety of the Microcutter stapling /cutting device in patients requiring the transection, resection or anastomosis of gastrointestinal tissue in a post-market approval study.
Detailed description
A prospective, open label, multi-center non-inferiority safety study with an all-comers enrollment of patients requiring surgical stapling of the stomach and/or intestine according to the labeled indications contained in the approved labeling. Up to 178 subjects consented for a 1-month clinical follow-up evaluation will be enrolled. Primary endpoint is to statistical non-inferiority of composite major adverse event rate (composite of infection (non-dermal), dehiscence, bleeding, and strictures) in study patients when compared to composite major adverse event rate (composite of infection (non-dermal), dehiscence, bleeding, and strictures) as derived from a comprehensive analysis of the medical literature. The comparison will be performed for cumulative events up to 30 days postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MicroCutter Stapling Device | Active comparator | Device: Microcutter XPRESS and Microcutter XCHANGEPatients undergoing surgical treatment with the MicroCutter Stapling Device |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients requiring surgical treatment where the use of a surgical stapler is anticipated
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Microcutter XPRESS and Microcutter XCHANGEAlso: MicroCutter XPRESS30, MicroCutter XPRESS45, MicroCutter XCHANGE30Surgical stapling devices | Device | MicroCutter Stapling Device |
Primary outcome
Composite adverse event rate
Time frame: up to 30 days postoperatively
Composite event rate is a compilation of the following stapling related adverse event rates: bleeding, leakage, stricture and infection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2013.
- Manufacturer of MicroCutterLink provided by the sponsor.
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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.
Andreas Kithe, M.D. principal investigator
DRK-Krankenhaus Clementinenhaud, Hannover
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 Microcutter XPRESS and Microcutter XCHANGE in people with Thoracic, run by Cardica, Inc at 1 site in Germany.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 9 Aug 2013. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Composite adverse event rate (time frame: up to 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2013.