Rectal CancerNCT01790230
LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection
A study testing LifeSeal™ Kit in people with Rectal Cancer, run by LifeBond Ltd. at 1 site in Sweden.
Trial summary
A preliminary Study in Subjects Undergoing Low Anterior Resection Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- LifeSeal™ Kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2013to Aug 2013
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject, or authorized representative, signed a written Informed Consent
- Subject is at least 18 years of age
- Subject is scheduled for elective open resection
- Stapled anastomosis created within 10cm of the anal verge
- Subject is willing to comply with the follow-up requirements of the study
Who cannot join
- Subject has a history of hypersensitivity to porcine derived gelatin or collagen
- Subject has unacceptable baseline hematological results
- Subject on chronic preoperative treatment with steroids and anticoagulants
- Subject with elevated liver function tests
- Subject with abnormal kidney function
- Subject with a BMI higher than 35
Show all 12Show fewer
- Subject participating in any other study for either drug or device which can influence collection of valid data under this study
- Subject with a history of MI, CVA or ASA status IV or a life expectancy of less than 1 year
- Anastomosis was performed differently from what was defined
- Subject received intraoperative sealant, glue or any buttressing material for the study related anastomosis, other than the LifeSeal™
- Subject has intraoperative bleeding in excess of 500cc
- Subject has peritoneal carcinomatosis
Trial locations and contacts
1 site in 1 country.
About this study
A preliminary Study in Subjects Undergoing Low Anterior Resection
- Conditions
- Rectal Cancer
- Being tested
- LifeSeal™ Kit
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifeSeal™ KitDevice
Application of LifeSeal™ Kit for staple line reinforcement during open GI surgeries in Low Anterior Resection
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Standard of Care Arm - subjects treated by routine manner |
| LifeSeal™ Kit | Experimental | LifeSeal™ Kit Arm - subjects treated with the LifeSeal™ Kit device + Standard of Care treatment Receives: Device: LifeSeal™ Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of subject's safety by incidence of related Adverse Events
Measured: Approx. 1 month
Secondary outcomes (1)
Assessment of the device's application technique
Surgeon will complete a questionnaire regarding the device use and ease of application
Measured: Intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeBond Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790230
- Sponsor's protocol ID
- CLP-LS-0105
- Status last verified
- Sep 2013
- First submitted
- 31 Jan 2013
- Last updated
- 4 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection
- ClinicalTrials.gov ID
- NCT01790230
- Acronym / sponsor ID
- CLP-LS-0105
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- LifeBond Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 13 Feb 2013 (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.
A preliminary Study in Subjects Undergoing Low Anterior Resection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Standard of Care Arm - subjects treated by routine manner |
| LifeSeal™ Kit | Experimental | Device: LifeSeal™ KitLifeSeal™ Kit Arm - subjects treated with the LifeSeal™ Kit device + Standard of Care treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject, or authorized representative, signed a written Informed Consent
- Subject is at least 18 years of age
- Subject is scheduled for elective open resection
- Stapled anastomosis created within 10cm of the anal verge
- Subject is willing to comply with the follow-up requirements of the study
Key exclusion criteria (12 listed)
- Subject has a history of hypersensitivity to porcine derived gelatin or collagen
- Subject has unacceptable baseline hematological results
- Subject on chronic preoperative treatment with steroids and anticoagulants
- Subject with elevated liver function tests
- Subject with abnormal kidney function
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 |
|---|---|---|
| LifeSeal™ KitApplication of LifeSeal™ Kit for staple line reinforcement during open GI surgeries in Low Anterior Resection | Device | LifeSeal™ Kit |
Primary outcome
Assessment of subject's safety by incidence of related Adverse Events
Time frame: Approx. 1 month
1 secondary outcome
Assessment of the device's application technique
Time frame: Intra-operative
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 4 Sep 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LifeSeal™ Kit in people with Rectal Cancer, run by LifeBond Ltd. at 1 site in Sweden.
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 5 inclusion and 12 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 4 Sep 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 Sweden. 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?
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?
Assessment of subject's safety by incidence of related Adverse Events (time frame: Approx. 1 month). 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 4 Sep 2013.