Rectal CancerPhase 3NCT02907385
Efficacy and Safety of LifeSeal™ Kit for Colorectal Staple Line Sealing
A Phase 3 study testing LifeSeal™ Kit in people with Rectal Cancer and Anastomotic Leak, run by LifeBond Ltd. at 39 sites in 7 countries.
Trial summary
LifeSeal™ Kit, surgical sealant designed for staple-line reinforcement that is applied over the anastomotic line to prevent bowel content leakage until full physiological function is restored. RATIONALE : Postoperative anastomotic leakage is one of the most devastating and feared complications in colorectal surgery. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Rectal Cancer, Anastomotic Leak
- 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
- 736 participants
- Where
- 39 sitesin 7 countries
- Study dates
- Nov 2016to Sep 2020
- Phase
- Phase 3
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 21 years of age at Screening Visit.
- Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
- Subject is diagnosed with colorectal cancer
- Subject is scheduled for elective open, laparoscopic or robot assisted surgery involving the creation of a circular stapled anastomosis created within 10cm from the anal verge.
- Procedure involving Total Mesorectal Excision by an abdominal or transanal approach.
- Female subjects in child bearing age must be using acceptable contraception methods such as hormonal contraception or two forms of barrier contraception. Acceptable contraception must be used consistently from 30 days before screening until 3 years following surgery
Who cannot join
- Pre-operative exclusion criteria:
- Female subject who is pregnant, breastfeeding, or if of child bearing potential is unwilling to practice birth control until 3 years following surgery.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data.
- Subject has a history of hypersensitivity to porcine derived gelatin or collagen.
- Subject has a history of hypersensitivity to microbial Transglutaminase.
- Subject has a known dysfibrinogenemia, hypofibrinogenemia or a fibrinogenemia, without preoperative correction of fibrinogen levels.
Show all 23Show fewer
- Subject participating in any other study involving an investigational (unapproved) drug or device within the past 60 days.
- Subject participating in studies involving approved drug or device will be enrolled only following a mutual consideration of the investigator together with the Sponsor.
- Subject with a BMI ≥50, which may interfere with access to the surgical site and increase overall operative risk.
- Subject with American Society of Anesthesiology (ASA) status higher than 3.
- Avastin use within 30 days prior to surgery.
- Subject who has undergone a prior pelvic anastomosis.
- Subject is scheduled for another surgery during the first 6 months following surgery (not including stoma closure ,placement of port for chemotherapy or ureter stent insertion).
- Subject with an active abdominal or pelvic infection at the operation site.
- Subject has been previously treated with LifeSeal™ Surgical Sealant.
- Intra-operative Exclusion Criteria
- Anastomosis or procedure (TME) was performed differently from what was defined in the inclusion criteria.
- Subject received intra-operative sealant, glue or any buttressing material other than the LifeSeal™ Surgical Sealant.
- Subject has peritoneal carcinomatosis.
- Subject requires additional unrelated anastomosis during the surgery.
- Subject is going through another surgical procedure (other than ileostomy or adhesiolysis) during the surgery.
- Excessive bleeding (above 500cc) identified prior to anastomosis formation with the need for intra-operative blood transfusion.
- -
Trial locations and contacts
39 sites in 7 countries.
39 sites in 7 countries
United States23 sites
Albany medical center
Albany, New York
Johns Hopkins Hospital
Baltimore, Maryland
University of Vermont
Burlington, Vermont
University of Virginia
Charlottesville, Virginia
University of Chicago
Chicago, Illinois
Cleveland Clinic
Cleveland, Ohio
University Hospital Cleveland Medical Center
Cleveland, Ohio
Duke University
Durham, South Carolina
Florida Hospital
Florida City, Florida
Spectrum Health
Grand Rapids, Michigan
Franciscan
Indianapolis, Indiana
Indiana University
Indianapolis, Indiana
Ochsner Clinic Foundation
Jefferson, Louisiana
University of Southern CA
Los Angeles, California
Medical College of Wisconsin
Milwaukee, Wisconsin
New York University
New York, New York
Washington University
St Louis, Missouri
Stanford University
Stanford, California
Penn state university
State College, Pennsylvania
Tampa General Hospital
Tampa, Florida
Cleveland Clinic Florida
Weston, Florida
Medical University SC (MUSC)
Worcester, Massachusetts
University of Massachusetts
Worcester, Massachusetts
Belgium4 sites
OLV Ziekenhuis Aalst
Aalst
Ziekenhuis Oost-Limburg
Genk
Gent University Hospital
Ghent
University Hospital Leuven
Leuven
Israel3 sites
Beilinson Rabin Medical Center
Petah Tikva
Sourasky Medical Center
Tel Aviv
Assaf Harofeh Medical Center
Tzrifin
Italy3 sites
Policlinico S.Orsola Malpighi
Bologna
Humanitas Research Hospital
Milan
University of Padova
Padova
Sweden3 sites
Lund University Hospital
Malmö
Karolinska University Hospital
Stockholm
Uppsala University Hospital
Uppsala
Denmark2 sites
Bispebjerg Hospital
Copenhagen
Zealand University Hospital
Roskilde
About this study
Official title: Efficacy and Safety of LifeSeal™ Kit for Staple Line Sealing in Colorectal and Coloanal Anastomoses: A Prospective Randomized Study
LifeSeal™ Kit, surgical sealant designed for staple-line reinforcement that is applied over the anastomotic line to prevent bowel content leakage until full physiological function is restored.
RATIONALE : Postoperative anastomotic leakage is one of the most devastating and feared complications in colorectal surgery. The risk of postoperative anastomotic leakage varies widely depending on the level of anastomosis while the risk is higher in low anastomosis.
Read more
In order to best demonstrate the benefits of LifeSeal™ in providing staple line reinforcement and helping to reduce leaks, the study includes high risk anastomoses, defined as colorectal and coloanal anastomoses performed within 10 cm from the anal verge.
STUDY DESIGN: This study is designed as a prospective, multi-center, multinational randomized, single-blind, double armed study PRIMARY OBJECTIVE: The primary objective of this study is to assess the efficacy and safety of LifeSeal™ Kit as measured by the change in overall anastomotic leak rates in subjects undergoing low anterior resection with an anastomosis below 10 cm from the anal verge, over the first 17 weeks after surgery.
SECONDARY OBJECTIVES: The secondary objective of this study is to assess the incidence of post-operative leaks and additional benefits that could be related to the use of LifeSeal™ Kit such as reducing the severity and improving the outcome of a leak once it has occurred. In addition, the study will allow for collection and analysis of additional safety data and usability assessment of the device, medical resource utilization, and health related quality of life measures.
- Conditions
- Rectal Cancer, Anastomotic Leak
- Being tested
- LifeSeal™ Kit
- Keywords
- Rectal Cancer, Low Anterior Resection, LifeSeal, Surgical Sealant
- Medical subject headings
- Rectal Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifeSeal™ KitDevice
LifeSeal™ Kit is applied as an additional protective layer over a stapled anastomosis
| Study group | Role | What they receive |
|---|---|---|
| LifeSeal™ Kit | Experimental | Stapled Anastomosis is performed according to Standard of Care (SoC) with the addition of LifeSeal™ Kit application during surgery. Receives: Device: LifeSeal™ Kit |
| Standard of Care | No intervention | Stapled Anastomosis is performed according to SoC without LifeSeal™ reinforcement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of overall anastomotic leak
Measured: Up to 17 weeks post surgery
Secondary outcomes (1)
Incidence of post operative anastomotic leaks
Measured: Up to 17 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2018 (estimated)
- Study completionSep 2020 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 736 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LifeBond Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907385
- Sponsor's protocol ID
- CLP-LS-0131
- Status last verified
- Mar 2018
- First submitted
- 15 Sep 2016
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of LifeSeal™ Kit for Staple Line Sealing in Colorectal and Coloanal Anastomoses: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02907385
- Acronym / sponsor ID
- CLP-LS-0131
- Conditions
- Rectal Cancer, Anastomotic Leak
- Keywords
- Rectal Cancer, Low Anterior Resection, LifeSeal, Surgical Sealant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 736 participants (estimated)
- Lead sponsor
- LifeBond Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 20 Sep 2016 (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.
LifeSeal™ Kit, surgical sealant designed for staple-line reinforcement that is applied over the anastomotic line to prevent bowel content leakage until full physiological function is restored.
RATIONALE : Postoperative anastomotic leakage is one of the most devastating and feared complications in colorectal surgery. The risk of postoperative anastomotic leakage varies widely depending on the level of anastomosis while the risk is higher in low anastomosis.
In order to best demonstrate the benefits of LifeSeal™ in providing staple line reinforcement and helping to reduce leaks, the study includes high risk anastomoses, defined as colorectal and coloanal anastomoses performed within 10 cm from the anal verge.
STUDY DESIGN: This study is designed as a prospective, multi-center, multinational randomized, single-blind, double armed study PRIMARY OBJECTIVE: The primary objective of this study is to assess the efficacy and safety of LifeSeal™ Kit as measured by the change in overall anastomotic leak rates in subjects undergoing low anterior resection with an anastomosis below 10 cm from the anal verge, over the first 17 weeks after surgery.
SECONDARY OBJECTIVES: The secondary objective of this study is to assess the incidence of post-operative leaks and additional benefits that could be related to the use of LifeSeal™ Kit such as reducing the severity and improving the outcome of a leak once it has occurred. In addition, the study will allow for collection and analysis of additional safety data and usability assessment of the device, medical resource utilization, and health related quality of life measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LifeSeal™ Kit | Experimental | Device: LifeSeal™ KitStapled Anastomosis is performed according to Standard of Care (SoC) with the addition of LifeSeal™ Kit application during surgery. |
| Standard of Care | No intervention | –Stapled Anastomosis is performed according to SoC without LifeSeal™ reinforcement. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female ≥ 21 years of age at Screening Visit.
- Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
- Subject is diagnosed with colorectal cancer
- Subject is scheduled for elective open, laparoscopic or robot assisted surgery involving the creation of a circular stapled anastomosis created within 10cm from the anal verge.
- Procedure involving Total Mesorectal Excision by an abdominal or transanal approach.
Key exclusion criteria (23 listed)
- Female subject who is pregnant, breastfeeding, or if of child bearing potential is unwilling to practice birth control until 3 years following surgery.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data.
- Subject has a history of hypersensitivity to porcine derived gelatin or collagen.
- Subject has a history of hypersensitivity to microbial Transglutaminase.
- Subject has a known dysfibrinogenemia, hypofibrinogenemia or a fibrinogenemia, without preoperative correction of fibrinogen levels.
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™ KitLifeSeal™ Kit is applied as an additional protective layer over a stapled anastomosis | Device | LifeSeal™ Kit |
Primary outcome
Incidence of overall anastomotic leak
Time frame: Up to 17 weeks post surgery
1 secondary outcome
Incidence of post operative anastomotic leaks
Time frame: Up to 17 weeks post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
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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.
39 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LifeSeal™ Kit in people with Rectal Cancer and Anastomotic Leak, run by LifeBond Ltd. at 39 sites in 7 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 6 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, Belgium, Israel, Italy, Sweden and 2 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Incidence of overall anastomotic leak (time frame: Up to 17 weeks post surgery). 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 Mar 2018.