Open/ Laparoscopic/ Robotic Resection of the ColonNCT04854473
Collection of Electrophysiological Data During Colon Resection
A study testing Exero Medical Leak Detection System in people with Open/ Laparoscopic/ Robotic Resection of the Colon, run by Exero Medical Ltd. at 1 site in Israel.
Trial summary
The study is conducted to record continuous electrophysiological signals from intact and ischemic bowel tissue during colonic resection surgery, in order to train the Exero Medical Leak Detection System classification algorithm on detection of ischemic conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open/ Laparoscopic/ Robotic Resection of the Colon
- What is being tested?
- Exero Medical Leak Detection System
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteIsrael
- Study dates
- 4 Jun 2020to 17 Sep 2020
- 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
- Age ≥ 18 years.
- Patient is scheduled for open colonic resection, (right hemicolectomy, left hemicolectomy, sigmoidectomy, anterior resection or subtotal colectomy) surgery.
- Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out.
Who cannot join
- Subject has gastroparesis.
- Subject has significant multisystem (autonomic) diseases.
- Subject has a body mass Index greater than 35 kg/m2
- Subject has an autoimmune disorder requiring therapy in the preceding 2 years.
- Subject has significant cardiac arrhythmia or ectopy.
- Obstructing lesion and pre obstruction bowel dilatation
Show all 13Show fewer
- Subject has an existing implanted electrical stimulator (e.g., pacemaker.
- Subject requires chronic anticoagulant therapy
- Subject is currently enrolled in other potentially confounding research.
- Pregnancy
- Current alcohol abuse
- Subject poses a significant general anesthesia risk
- Subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Data Collection Study - Recording Electro-physiological Signals From Intact (to be Resected, Pathological) and Ischemic Bowel Tissue During Open Colonic Surgery.
The study is conducted to record continuous electrophysiological signals from intact and ischemic bowel tissue during colonic resection surgery, in order to train the Exero Medical Leak Detection System classification algorithm on detection of ischemic conditions.
- Being tested
- Exero Medical Leak Detection System
- Keywords
- Exero, anastomotic leak, impedance, ischemia, colon, bowel
- Medical subject headings
- Anastomotic Leak, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exero Medical Leak Detection SystemDevice
the Exero Leak Detection System components used in this study are:
- Smart drain - a surgical drain with added sensing electrodes
- Transceiver /Recording Unit (TRU) - a wearable placed outside the body on intact skin and is connected to the implanted electrodes. The unit also acts as a wireless connection to the Monitoring Subsystem.
- Monitoring Subsystem - a tablet or a computer connected wirelessly to the transceiver providing logging, applying analysis algorithms on the logged signals and providing indication/alerts to the medical staff derived from the signals recorded by the electrodes.
| Study group | Role | What they receive |
|---|---|---|
| Impedance measurement | Experimental | Subjects with Exero's Smart Drain Device Attached This arm contains subjects which will have Exero's leak detection Device used: Exero Smart Drain is placed on their large bowel during colonic resection surgery (either open, laparoscopic or robotic). The study aims to demonstrate that the parameters measured by the device in in-vivo, non-disrupted tissue are different than parameters measured in ischemic tissue. Once this data is collected a detection algorithm can be trained. This procedure will add no more than 20 minutes to the existing procedure that is performed per hospital standard overall and will enable collection of control vs. ischemia induced clinical data, essential to developing the detection algorithms. Receives: Device: Exero Medical Leak Detection System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functionality of signal measurement
Baseline data collected from the intended bowel segment to be resected, prior to tissue manipulation, is compared to the data recorded after the ischemia induced by the resection procedure.
Measured: 10 minutes
Secondary outcomes (1)
Occurrence of adverse events
Adverse events both expected and unexpected, related or unrelated to study device or procedure, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start4 Jun 2020
- Primary completion17 Sep 2020
- Study completion17 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open/ Laparoscopic/ Robotic Resection of the ColonStudies 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exero Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nir Wasserberg, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854473
- Sponsor's protocol ID
- CLP-01
- Status last verified
- May 2021
- First submitted
- 18 Apr 2021
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection Study - Recording Electro-physiological Signals From Intact (to be Resected, Pathological) and Ischemic Bowel Tissue During Open Colonic Surgery.
- ClinicalTrials.gov ID
- NCT04854473
- Acronym / sponsor ID
- CLP-01
- Keywords
- Exero, anastomotic leak, impedance, ischemia, colon, bowel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Exero Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- 17 Sep 2020 (actual)
- Study completion
- 17 Sep 2020 (actual)
- First posted
- 22 Apr 2021 (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 study is conducted to record continuous electrophysiological signals from intact and ischemic bowel tissue during colonic resection surgery, in order to train the Exero Medical Leak Detection System classification algorithm on detection of ischemic conditions.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Impedance measurement | Experimental | Device: Exero Medical Leak Detection SystemSubjects with Exero's Smart Drain Device Attached This arm contains subjects which will have Exero's leak detection Device used: Exero Smart Drain is placed on their large bowel during colonic resection surgery (either open, laparoscopic or robotic). The study aims to demonstrate that the parameters measured by the device in in-vivo, non-disrupted tissue are different than parameters measured in ischemic tissue. Once this data is collected a detection algorithm can be trained. This procedure will add no more than 20 minutes to the existing procedure that is performed per hospital standard overall and will enable collection of control vs. ischemia induced clinical data, essential to developing the detection algorithms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Patient is scheduled for open colonic resection, (right hemicolectomy, left hemicolectomy, sigmoidectomy, anterior resection or subtotal colectomy) surgery.
- Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out.
Key exclusion criteria (13 listed)
- Subject has gastroparesis.
- Subject has significant multisystem (autonomic) diseases.
- Subject has a body mass Index greater than 35 kg/m2
- Subject has an autoimmune disorder requiring therapy in the preceding 2 years.
- Subject has significant cardiac arrhythmia or ectopy.
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 |
|---|---|---|
| Exero Medical Leak Detection Systemthe Exero Leak Detection System components used in this study are: * Smart drain - a surgical drain with added sensing electrodes * Transceiver /Recording Unit (TRU) - a wearable placed outside the body on intact skin and is connected to the implanted electrodes. The unit also acts as a wireless connection to the Monitoring Subsystem. * Monitoring Subsystem - a tablet or a computer connected wirelessly to the transceiver providing logging, applying analysis algorithms on the logged signals and providing indication/alerts to the medical staff derived from the signals recorded by the electrodes. | Device | Impedance measurement |
Primary outcome
Functionality of signal measurement
Time frame: 10 minutes
Baseline data collected from the intended bowel segment to be resected, prior to tissue manipulation, is compared to the data recorded after the ischemia induced by the resection procedure.
1 secondary outcome
Occurrence of adverse events
Time frame: 10 minutes
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 6 May 2021.
- Individual participant dataSharing planned: No
Related trials for Open/ Laparoscopic/ Robotic Resection of the Colon
RecruitingObservational study
Patient Reported Outcomes Following Cancer of the Rectum
Sphincter Ani Incontinence, Rectal 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.
Nir Wasserberg, MD principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exero Medical Leak Detection System in people with Open/ Laparoscopic/ Robotic Resection of the Colon, run by Exero Medical Ltd. at 1 site in Israel.
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 13 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 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Functionality of signal measurement (time frame: 10 minutes). 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 6 May 2021.