Gastrointestinal Anastomotic ComplicationSAFE-1NCT03352570
a Study to Investigate the Efficacy, and Safety of the Colovac Colorectal Anastomosis Protection Device.
A study testing COLOVAC in people with Gastrointestinal Anastomotic Complication, run by Safeheal at 3 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate theColovac device, a single use, temporary intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastrointestinal Anastomotic Complication
- What is being tested?
- COLOVAC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 14 Nov 2017to 26 Mar 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be >= 18 and <= 65 years old
- Indicated for colorectal resection
- Patient has been assessed by a multi-disciplinary team and it was determined that as per standard of care, they are eligible to bear a diverting ostomy
- Willing to comply with protocol-specified follow-up evaluations
- Signed Informed Consent
Who cannot join
- Patient with inflammatory bowel disease
- Pregnant or nursing female subject (a pregnancy test should be conducted the day prior to the procedure for all women in age of procreating)
- Known allergy to nickel or other components of the Colovac kit
- Any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimal participation in the study, including:
- immunodeficiency
- steroid therapy
Show all 18Show fewer
- infections at the time of intervention
- major surgical or interventional procedures within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study
- diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis
- preexisting sphincter problems or evidence of extensive local disease in the pelvis
- blood loss (> 500 cc)
- non amended peroperative anastomosis failure
- intra-operative adverse events
- malnourishment
- obesity (BMI > 35)
- history of excessive smoking and alcohol use
- The subject is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study
- Patient unable to give consent
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
France2 sites
Hopital Saint-Antoine
Paris, 75012
Ihu Strasbourg
Strasbourg, 67091
About this study
Official title: Safe (Safe Anastomosis Feasibility Evaluation)-1 Study : a Study to Investigate the Efficacy, Mechanism of Action and Safety of the Colovac Colorectal Anastomosis Protection Device First-In-man Clinical Investigation Study
The purpose of this study is to evaluate theColovac device, a single use, temporary intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic).
- Being tested
- COLOVAC
- Keywords
- anastomotic leakage, fistula
- Medical subject headings
- Anastomotic Leak, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COLOVACDevice
The intervention consists in the placement of the Colovac device, during the colorectal surgery, Once the colorectal anastomosis has been completed as per standard care and the water-thightness of the anastomosis has been verified.
| Study group | Role | What they receive |
|---|---|---|
| COLOVAC device | Experimental | colorectal surgery performed per standard of care with deployment of the Colovac device to protect the anastomosis site Receives: Device: COLOVAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adverse events
occurence of intraoperative and postoperative complications
Measured: up to 3 months
Secondary outcomes (10)
device introduction success rate
Ability to introduce, deploy and retrieve the Colovac Anastomosis Protection Device in/from the desired location in the colon
Measured: During surgery
Device placement success rate
Measured by number of successful placement divided by overall placement number
Measured: During surgery
Colovac procedure time
Procedure duration measured in minutes
Measured: During surgery
Migration rate of the Colovac device
defined by the number of devices migrated over the anastomosis divided by the number of devices placed
Measured: During surgical procedure and up to 15 days after placement
Device retrieval success rate
Retrieval success rate measured by number of successful retrieval without complication divided by overall number of retrieval performed
Measured: At 14 days after device placement
rate of digestive disorders
Measured as number of patients presenting digestive disorders divided by overall number of patients
Measured: up to 15 days after surgery
level of patient comfort measured using NIH's PROMIS health measurement questionnaires
measures using health measurement questionnaires to assess parameters like pain (visual analogue scale - 1 : no pain - 10 : worse pain ever); bowel incontinence (visual analogue scale - 1 : no incontinence - 10 : uncontrollable incontinence), diarrhea (visual analogue scale - 1 : no pain - 10 : worse pain ever); bowel incontinence (visual analogue scale - 1 : no diarrhea - 10 : more than 3 episodes of diarrhea per day)
Measured: up to 15 days after surgery
occurence of anastomosis leakage
measured as mean number of anastomosis leakage episodes per patient
Measured: up to 3 months after initial surgery
occurrence of anastomosis fistula
measured as mean number of anastomosis fisutal episodes per patient
Measured: up to 3 months after initial surgery
occurrence of anastomotic abcesses
measured as mean number of anastomosis abcess episodes per patient
Measured: up to 3 months after initial surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start14 Nov 2017
- Primary completion26 Sep 2018
- Study completion26 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Anastomotic ComplicationStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Safeheal
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352570
- Sponsor's protocol ID
- SAFE-1
- Acronym
- SAFE-1
- Status last verified
- Oct 2019
- First submitted
- 13 Nov 2017
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe (Safe Anastomosis Feasibility Evaluation)-1 Study : a Study to Investigate the Efficacy, Mechanism of Action and Safety of the Colovac Colorectal Anastomosis Protection Device First-In-man Clinical Investigation Study
- ClinicalTrials.gov ID
- NCT03352570
- Acronym / sponsor ID
- SAFE-1 / SAFE-1
- Keywords
- anastomotic leakage, fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- SafehealIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 26 Sep 2018 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 24 Nov 2017 (actual)
- 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 theColovac device, a single use, temporary intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COLOVAC device | Experimental | Device: COLOVACcolorectal surgery performed per standard of care with deployment of the Colovac device to protect the anastomosis site |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject must be >= 18 and <= 65 years old
- Indicated for colorectal resection
- Patient has been assessed by a multi-disciplinary team and it was determined that as per standard of care, they are eligible to bear a diverting ostomy
- Willing to comply with protocol-specified follow-up evaluations
- Signed Informed Consent
Key exclusion criteria (18 listed)
- Patient with inflammatory bowel disease
- Pregnant or nursing female subject (a pregnancy test should be conducted the day prior to the procedure for all women in age of procreating)
- Known allergy to nickel or other components of the Colovac kit
- Any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimal participation in the study, including:
- The subject is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study
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 |
|---|---|---|
| COLOVACThe intervention consists in the placement of the Colovac device, during the colorectal surgery, Once the colorectal anastomosis has been completed as per standard care and the water-thightness of the anastomosis has been verified. | Device | COLOVAC device |
Primary outcome
Rate of adverse events
Time frame: up to 3 months
occurence of intraoperative and postoperative complications
10 secondary outcomes
device introduction success rate
Time frame: During surgery
Device placement success rate
Time frame: During surgery
Colovac procedure time
Time frame: During surgery
Migration rate of the Colovac device
Time frame: During surgical procedure and up to 15 days after placement
Device retrieval success rate
Time frame: At 14 days after device placement
rate of digestive disorders
Time frame: up to 15 days after surgery
level of patient comfort measured using NIH's PROMIS health measurement questionnaires
Time frame: up to 15 days after surgery
occurence of anastomosis leakage
Time frame: up to 3 months after initial surgery
occurrence of anastomosis fistula
Time frame: up to 3 months after initial surgery
occurrence of anastomotic abcesses
Time frame: up to 3 months after initial surgery
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 10 Oct 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COLOVAC in people with Gastrointestinal Anastomotic Complication, run by Safeheal 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 5 inclusion and 18 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 10 Oct 2019. 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 France, Belgium. 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 adverse events (time frame: up to 3 months). 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 10 Oct 2019.