Elective Surgical Procedures, Digestive SystemNCT02825173
Seal-G Safety Study
A study testing Seal-G in people with Elective Surgical Procedures, Digestive System, run by Sealantis Ltd. at 3 sites in 2 countries.
Trial summary
The purpose of this study is to farther assess the safety of the Seal-G Surgical Sealant for the reinforcement and protection of gastrointestinal anastomosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elective Surgical Procedures, Digestive System
- What is being tested?
- Seal-G
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Aug 2016to 2 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is ≥ 18 years old.
- Subject is planned to undergo an elective open or laparoscopic colonic resection with the creation of an anastomosis (extracorporeal if laparoscopic surgery is performed).
- Subject signs and dates a written ICF, indicates an understanding of the study procedures and follow-up requirements and is willing to comply with them.
Who cannot join
- Subject, undergoing low anterior resection
- Subject is planned to undergo an emergency procedure
- Subject has a diagnosis of bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, and carcinomatosis
- Subject treated with immunosuppressive agents within 28 days prior to study enrollment (including corticosteroids)
- Serious or uncontrolled co-existent diseases (e.g. severe cardiovascular disease, congestive heart failure, recent myocardial infarction, significant vascular disease, active or uncontrolled autoimmune disease, active or uncontrolled infection)
- Subject who according to the investigator clinical judgement is at risk for anastomosis dehiscence
Show all 20Show fewer
- Subject has participated in another clinical study which may affect this study's outcomes within the last 30 days
- Subject's ASA (American Society of Anesthesiology) score ≥ 4
- Subject's BMI > 34 or <16
- Subject known to have distant metastases, such as liver, lung, bone etc. metastases (not including local and regional lymph nodes)
- Subject with a life expectancy of less than 1 year
- Subject requires more than one anastomosis during the surgery
- Woman who is known to be pregnant
- Mentally handicapped, prisoners, or legally incompetent
- Intraoperative Exclusion Criteria:
- Subjects whom anastomosis is less than 10 cm from the anal verge
- The full circumference of the anastomosis is not accessible for Seal-G application
- Subject received intraoperative sealant, glue or any buttressing material for the study related anastomosis, other than the Seal-G
- Subject has excessive intraoperative bleeding prior to the anastomosis formation as assessed by the investigator (estimated in excess of 500mL)
- Subject has peritoneal carcinomatosis
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Official title: A Prospective, Multi-center, Open Label, Non-randomized Study, of Seal-G Surgical Sealant for the Reinforcement of Gastrointestinal Anastomosis
The purpose of this study is to farther assess the safety of the Seal-G Surgical Sealant for the reinforcement and protection of gastrointestinal anastomosis.
Read the detailed description
Pre-Surgery:
Screening will be performed among adult subjects who are scheduled for an elective colorectal surgery. Pre-surgery assessments (after completion of consent process and signed ICF) will be according to the routine practice.
Intra-operative:
During surgery, an assessment of the intra-operative exclusion criteria will be performed. If the subject does not meet any of the exclusion criteria, the subject will be further enrolled. Surgery will be performed according to the site standard of care (routine practice). Anastomosis will be created either using a stapler device (linear or circular), according to manufacture IFU (Instructions for use) or hand suture according to surgeon best practice technique. Once anastomosis has been created, surgeon will verify the anastomosis and mucosal donuts integrity.
Device (Seal-G) application on anastomotic site
Post-operative follow-up: Follow-up evaluations will be performed daily while hospitalized. There will be one postoperative follow up at one month - clinic visit
- Being tested
- Seal-G
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seal-GDevice
Also called Seal-G Surgical Sealant
Intervention:
Device: Seal-G Seal-G is applied adjunctively to cover standard closure techniques
| Study group | Role | What they receive |
|---|---|---|
| Seal-G | Experimental | A surgical sealant intended for use as an adjunct to standard closure techniques for reinforcement and protection of gastrointestinal anastomoses. Receives: Device: Seal-G |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of device related complications
Measured: Postoperative to end of follow up (30±7 days)
Secondary outcomes (4)
Overall rate of complications
Measured: Postoperative to end of follow up (30±7 days)
Postoperative length of hospitalization stay
Measured: Postoperative till time for "ready to be discharged" (10±4 days)
Duration of sealant application
Measured: Intraoperative: starting from initial spreading on the treatment site to completion of curing, will be recorded (in minutes)
Ease of use of the device
Ease of use of the device will be rated using a Likert scale from 1 to 5 with: 1 being Very easy, 2 Easy, 3 Neutral, 4 Difficult and 5 being Very difficult. At the day of surgery (after surgery completed) the surgeon will complete a questionnaire regarding the device use and ease of application.
Measured: Intraoperative: device application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionNov 2016
- Study completion2 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Surgical Procedures, Digestive SystemStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sealantis Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rina Lev, PhD, Study director, Sealantis Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825173
- Sponsor's protocol ID
- DLG-072-01
- Status last verified
- Apr 2017
- First submitted
- 15 Jun 2016
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Open Label, Non-randomized Study, of Seal-G Surgical Sealant for the Reinforcement of Gastrointestinal Anastomosis
- ClinicalTrials.gov ID
- NCT02825173
- Acronym / sponsor ID
- DLG-072-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sealantis Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- 2 Dec 2016 (actual)
- First posted
- 7 Jul 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.
The purpose of this study is to farther assess the safety of the Seal-G Surgical Sealant for the reinforcement and protection of gastrointestinal anastomosis.
Detailed description
Pre-Surgery:
Screening will be performed among adult subjects who are scheduled for an elective colorectal surgery. Pre-surgery assessments (after completion of consent process and signed ICF) will be according to the routine practice.
Intra-operative:
During surgery, an assessment of the intra-operative exclusion criteria will be performed. If the subject does not meet any of the exclusion criteria, the subject will be further enrolled. Surgery will be performed according to the site standard of care (routine practice). Anastomosis will be created either using a stapler device (linear or circular), according to manufacture IFU (Instructions for use) or hand suture according to surgeon best practice technique. Once anastomosis has been created, surgeon will verify the anastomosis and mucosal donuts integrity.
Device (Seal-G) application on anastomotic site
Post-operative follow-up: Follow-up evaluations will be performed daily while hospitalized. There will be one postoperative follow up at one month - clinic visit
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Seal-G | Experimental | Device: Seal-GA surgical sealant intended for use as an adjunct to standard closure techniques for reinforcement and protection of gastrointestinal anastomoses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is ≥ 18 years old.
- Subject is planned to undergo an elective open or laparoscopic colonic resection with the creation of an anastomosis (extracorporeal if laparoscopic surgery is performed).
- Subject signs and dates a written ICF, indicates an understanding of the study procedures and follow-up requirements and is willing to comply with them.
Key exclusion criteria (20 listed)
- Subject, undergoing low anterior resection
- Subject is planned to undergo an emergency procedure
- Subject has a diagnosis of bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, and carcinomatosis
- Subject treated with immunosuppressive agents within 28 days prior to study enrollment (including corticosteroids)
- Serious or uncontrolled co-existent diseases (e.g. severe cardiovascular disease, congestive heart failure, recent myocardial infarction, significant vascular disease, active or uncontrolled autoimmune disease, active or uncontrolled infection)
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 |
|---|---|---|
| Seal-GAlso: Seal-G Surgical SealantIntervention: Device: Seal-G Seal-G is applied adjunctively to cover standard closure techniques | Device | Seal-G |
Primary outcome
Rate of device related complications
Time frame: Postoperative to end of follow up (30±7 days)
4 secondary outcomes
Overall rate of complications
Time frame: Postoperative to end of follow up (30±7 days)
Postoperative length of hospitalization stay
Time frame: Postoperative till time for "ready to be discharged" (10±4 days)
Duration of sealant application
Time frame: Intraoperative: starting from initial spreading on the treatment site to completion of curing, will be recorded (in minutes)
Ease of use of the device
Time frame: Intraoperative: device application
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 27 Apr 2017.
- Individual participant dataSharing planned: Undecided
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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.
Rina Lev, PhD study director
Sealantis Ltd.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seal-G in people with Elective Surgical Procedures, Digestive System, run by Sealantis Ltd. at 3 sites in 2 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 3 inclusion and 20 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 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel, Italy. 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?
Rate of device related complications (time frame: Postoperative to end of follow up (30±7 days)). 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 27 Apr 2017.