Rectal CancerNCT02046278
LifeSeal™ Pilot Study in Subjects Undergoing Circular Stapled Anastomosis Created Within 10 cm of the Anal Verge
A study testing LifeSeal™ Kit in people with Rectal Cancer, run by LifeBond Ltd. at 8 sites in 3 countries.
Trial summary
A Pilot Study in Subjects Undergoing circular stapled anastomosis created within 10 cm of the anal verge. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- 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
- 70 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Jan 2014to Aug 2016
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject, or authorized representative, signed a written Informed Consent Form
- Subject is 18 years or older
- Subject is scheduled for elective open or laparoscopic surgery involving the creation of a circular stapled anastomosis created within 10cm from the anal verge.
- If female - not be of child bearing potential, or be using acceptable contraception methods.
- Subject participating in studies involving approved drug or device will be enrolled only following a mutual consideration of the investigator together with the Sponsor.
Who cannot join
- Subject has a history of hypersensitivity to porcine derived gelatin or collagen
- Subject participating in any other study involving an investigational (unapproved) drug or device.
- Subject with a BMI higher than 40
- Female Subject states that she is pregnant or breast feeding
- Subject with ASA status higher than 3
- Avastin use within 30 days prior to surgery
- Subject who underwent a prior pelvic anastomosis
- Subject is scheduled for another surgery during the follow up period of this study (not including stoma closure)
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Belgium4 sites
OLV Ziekenhuis
Aalst
Ziekenhuis Oost-Limburg
Genk
University Hospital
Ghent
UZ Leuven
Leuven
Sweden3 sites
Skane University Hospital
Malmö
Karolinska Institutet
Stockholm
Uppsala University Hospital
Uppsala, SE-751 85
About this study
A Pilot Study in Subjects Undergoing circular stapled anastomosis created within 10 cm of the anal verge.
- 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
| Study group | Role | What they receive |
|---|---|---|
| Control arm - Standard of Care | No intervention | The anastomosis will be created using Standard of Care only |
| Device arm - Standard of Care + LifeSeal™ Kit | Experimental | The anastomosis will be created using SOC + LifeSeal™ Kit Receives: Device: LifeSeal™ Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the overall Subject safety by incidence of pre specified procedure related Adverse Events.
Measured: Up to 15 weeks
Secondary outcomes (1)
Performance Rate of anastomotic leak (both radiological and clinical leaks)
Measured: Up to 15 weeks post procedure or at stoma closure, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2014
- Study completionAug 2016
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
- 70 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
- NCT02046278
- Sponsor's protocol ID
- CLP-LS-0110
- Status last verified
- Aug 2016
- First submitted
- 23 Jan 2014
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LifeSeal™ Pilot Study in Subjects Undergoing Circular Stapled Anastomosis Created Within 10 cm of the Anal Verge
- ClinicalTrials.gov ID
- NCT02046278
- Acronym / sponsor ID
- CLP-LS-0110
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- LifeBond Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 27 Jan 2014 (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 Pilot Study in Subjects Undergoing circular stapled anastomosis created within 10 cm of the anal verge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm - Standard of Care | No intervention | –The anastomosis will be created using Standard of Care only |
| Device arm - Standard of Care + LifeSeal™ Kit | Experimental | Device: LifeSeal™ KitThe anastomosis will be created using SOC + LifeSeal™ Kit |
Who may qualify
- Ages
- 18 to 90 years
- 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 Form
- Subject is 18 years or older
- Subject is scheduled for elective open or laparoscopic surgery involving the creation of a circular stapled anastomosis created within 10cm from the anal verge.
- If female - not be of child bearing potential, or be using acceptable contraception methods.
- Subject participating in studies involving approved drug or device will be enrolled only following a mutual consideration of the investigator together with the Sponsor.
Key exclusion criteria (8 listed)
- Subject has a history of hypersensitivity to porcine derived gelatin or collagen
- Subject participating in any other study involving an investigational (unapproved) drug or device.
- Subject with a BMI higher than 40
- Female Subject states that she is pregnant or breast feeding
- Subject with ASA status higher than 3
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™ Kit | Device | Device arm - Standard of Care + LifeSeal™ Kit |
Primary outcome
Assessment of the overall Subject safety by incidence of pre specified procedure related Adverse Events.
Time frame: Up to 15 weeks
1 secondary outcome
Performance Rate of anastomotic leak (both radiological and clinical leaks)
Time frame: Up to 15 weeks post procedure or at stoma closure, whichever comes first
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 30 Aug 2016.
Related trials for Rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
8 sites in 3 countries: 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 8 sites in 3 countries.
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 8 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 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium, Sweden, Israel. 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 the overall Subject safety by incidence of pre specified procedure related Adverse Events. (time frame: Up to 15 weeks). 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 30 Aug 2016.