Anastomotic LeakEarly Phase 1NCT04253028
Use of NERv's Inline Device as an Early Diagnostic Method for Anastomotic Leak.
A Early Phase 1 study testing NERv's Inline Device in people with Anastomotic Leak, run by FluidAI Medical at 2 sites in Egypt.
Trial summary
NERv's early feasibility clinical trial is a first-in-human, multi-center, pre-market, non-randomized clinical trial intended to evaluate the safety and collect preliminary data necessary for the detection of clinical post-operative anastomotic/intraperitoneal leakages. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anastomotic Leak
- What is being tested?
- NERv's Inline Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesEgypt
- Study dates
- 29 Jan 2020to 15 Mar 2020
- Phase
- Early Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years - male or female
- Subject understands and has voluntarily signed and dated Informed Consent Form (ICF)
- Subjects must be willing to comply with trial requirements
- Subject has a peritoneal drain attached post-surgery
Who cannot join
- Plans that the subject will be discharged less than 8 hours post-surgery
- Involvement in the planning and conduct of the clinical investigation
- Subject is participating in another investigational drug or device study which would interfere with the endpoints and follow-ups of this study
- Subject is consuming steroid or anti-inflammatory medication
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Use of NERv's Inline Device for the Continuous Monitoring of pH and Conductance Measurements as an Early Diagnostic Method for Anastomotic Leak.
NERv's early feasibility clinical trial is a first-in-human, multi-center, pre-market, non-randomized clinical trial intended to evaluate the safety and collect preliminary data necessary for the detection of clinical post-operative anastomotic/intraperitoneal leakages.
NERv's Inline Device attaches to existing catheters or peritoneal drains that are currently being used in the medical industry. This allows the device to measure the pH and conductance of intraperitoneal fluids that typically get drained through peritoneal drains.
The purpose of NERv's feasibility clinical trial is to collect pH and conductance readings by analyzing peritoneal drainage fluid. Upon analyzing data collected from NERv's Inline Device a clinical model of pH and conductance will be created. The clinical model can then be used to determine if a complication is developing. For instance, boundaries (reading thresholds) can be established where if the signal goes outside the boundaries a complication could be identified. Specifically the ability to detect a post-operative complication known as anastomotic leakage; which is a dreaded complication associated with abdominal surgeries; will be the main focus of the study.
- Conditions
- Anastomotic Leak
- Being tested
- NERv's Inline Device
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NERv's Inline DeviceDevice
NERv's Inline Device attaches to existing catheters or peritoneal drains that are currently being used in the medical industry. This allows the device to measure the pH and conductance of intraperitoneal fluids that typically get drained through peritoneal drains.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with NERv's Inline Device Attached | Experimental | This arm contains subjects which will have NERv's Inline Device attached to their peritoneal drain after bariatric surgery (this includes: Roux-en-Y Gastric Bypass (RYGBP), Sleeve Gastrectomy (SG), Gastric Plication and Duodenal Switch). Receives: Device: NERv's Inline Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pH of Peritoneal Fluid
NERv's Inline Device will be collecting continuous pH measurements of fluid that travels across the peritoneal drain of bariatric surgery patients.
Measured: A clinical model of change in pH over time will be established once the study is completed (up to 28 weeks).
Change in Conductance of Peritoneal Fluid
NERv's Inline Device will be collecting continuous conductance measurements of fluid that travels across the peritoneal drain of bariatric surgery patients.
Measured: A clinical model of change in conductance over time will be established once the study is completed (up to 28 weeks).
Change in Temperature of Peritoneal Fluid
NERv's Inline Device will be collecting continuous temperature measurements of fluid that travels across the peritoneal drain of bariatric surgery patients.
Measured: A clinical model of change in temperature over time will be established once the study is completed (up to 28 weeks).
Number of Subjects with Device Related Adverse Events
an adverse event assesmtent will be performed in accordance to ISO 14155 standards to determine the number of device related adverse events.
Measured: The number of device related will be established once the study is completed (up to 28 weeks).
Secondary outcomes (1)
Investigator and Subject Feedback on Device's Ease of Use and Comfort level
Ease of use and comfort levels will be evaluated by collecting responses to a questionnaire that will be filled out by both the investigator/nurse and the subject.
Measured: Overall comfort level and ease of use will be established once the study is completed (up to 28 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start29 Jan 2020
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomotic LeakStudies 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
- Early Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- FluidAI Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Unity Health Toronto
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253028
- Sponsor's protocol ID
- CLS0005
- Status last verified
- Aug 2020
- First submitted
- 28 Jan 2020
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of NERv's Inline Device for the Continuous Monitoring of pH and Conductance Measurements as an Early Diagnostic Method for Anastomotic Leak.
- ClinicalTrials.gov ID
- NCT04253028
- Acronym / sponsor ID
- CLS0005
- Conditions
- Anastomotic Leak
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- FluidAI MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Unity Health Toronto
- Study start
- 29 Jan 2020 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 5 Feb 2020 (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.
NERv's early feasibility clinical trial is a first-in-human, multi-center, pre-market, non-randomized clinical trial intended to evaluate the safety and collect preliminary data necessary for the detection of clinical post-operative anastomotic/intraperitoneal leakages.
NERv's Inline Device attaches to existing catheters or peritoneal drains that are currently being used in the medical industry. This allows the device to measure the pH and conductance of intraperitoneal fluids that typically get drained through peritoneal drains.
The purpose of NERv's feasibility clinical trial is to collect pH and conductance readings by analyzing peritoneal drainage fluid. Upon analyzing data collected from NERv's Inline Device a clinical model of pH and conductance will be created. The clinical model can then be used to determine if a complication is developing. For instance, boundaries (reading thresholds) can be established where if the signal goes outside the boundaries a complication could be identified. Specifically the ability to detect a post-operative complication known as anastomotic leakage; which is a dreaded complication associated with abdominal surgeries; will be the main focus of the study.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with NERv's Inline Device Attached | Experimental | Device: NERv's Inline DeviceThis arm contains subjects which will have NERv's Inline Device attached to their peritoneal drain after bariatric surgery (this includes: Roux-en-Y Gastric Bypass (RYGBP), Sleeve Gastrectomy (SG), Gastric Plication and Duodenal Switch). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years - male or female
- Subject understands and has voluntarily signed and dated Informed Consent Form (ICF)
- Subjects must be willing to comply with trial requirements
- Subject has a peritoneal drain attached post-surgery
Key exclusion criteria (4 listed)
- Plans that the subject will be discharged less than 8 hours post-surgery
- Involvement in the planning and conduct of the clinical investigation
- Subject is participating in another investigational drug or device study which would interfere with the endpoints and follow-ups of this study
- Subject is consuming steroid or anti-inflammatory medication
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 |
|---|---|---|
| NERv's Inline DeviceNERv's Inline Device attaches to existing catheters or peritoneal drains that are currently being used in the medical industry. This allows the device to measure the pH and conductance of intraperitoneal fluids that typically get drained through peritoneal drains. | Device | Subjects with NERv's Inline Device Attached |
Primary outcome
Change in pH of Peritoneal Fluid
Time frame: A clinical model of change in pH over time will be established once the study is completed (up to 28 weeks).
NERv's Inline Device will be collecting continuous pH measurements of fluid that travels across the peritoneal drain of bariatric surgery patients.
Change in Conductance of Peritoneal Fluid
Time frame: A clinical model of change in conductance over time will be established once the study is completed (up to 28 weeks).
NERv's Inline Device will be collecting continuous conductance measurements of fluid that travels across the peritoneal drain of bariatric surgery patients.
Change in Temperature of Peritoneal Fluid
Time frame: A clinical model of change in temperature over time will be established once the study is completed (up to 28 weeks).
NERv's Inline Device will be collecting continuous temperature measurements of fluid that travels across the peritoneal drain of bariatric surgery patients.
Number of Subjects with Device Related Adverse Events
Time frame: The number of device related will be established once the study is completed (up to 28 weeks).
an adverse event assesmtent will be performed in accordance to ISO 14155 standards to determine the number of device related adverse events.
1 secondary outcome
Investigator and Subject Feedback on Device's Ease of Use and Comfort level
Time frame: Overall comfort level and ease of use will be established once the study is completed (up to 28 weeks).
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 12 Aug 2020.
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Anastomotic Leaks
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing NERv's Inline Device in people with Anastomotic Leak, run by FluidAI Medical at 2 sites in Egypt.
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 4 inclusion and 4 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 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in pH of Peritoneal Fluid (time frame: A clinical model of change in pH over time will be established once the study is completed (up to 28 weeks).). The study lists 4 primary outcomes in all. 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 12 Aug 2020.