PancreatitisCAMPNCT04350996
Continuous Alcohol Monitoring for Pancreatitis
An observational study of Pancreatitis and Alcohol Drinking, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose the research is to demonstrate the feasibility of using a transdermal alcohol sensing device (BACtrack Skyn), and to correlate biological and self-reported alcohol measures with the transdermal alcohol measures in patients with a history of pancreatitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatitis, Alcohol Drinking
- What is being tested?
- Wearable alcohol sensor
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2020to Jun 2021
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients will have acute or chronic pancreatitis without calcification and have alcohol consumption score of ≥ 3 as measured using the validated TWEAK scale.
Who may be able to join
- Aged 18-75 years at the time of eligibility assessment
- History of at least one AP per Revised Atlanta Classification (20) within past 3 years from screening, which requires two of the following evidence of pancreatitis:
- Abdominal pain consistent with AP (acute onset of a persistent, severe, epigastric pain often radiating to the back)
- Serum lipase activity (or amylase activity) at least three times greater than the upper limit of normal
- Characteristic findings of AP on contrast-enhanced computed tomography (CECT), magnetic resonance imaging (MRI) or transabdominal ultrasonography
- Access to a mobile or portable device that has the capability to sync to the BACtrack sensor and internet connection for syncing purposes.
Who cannot join
- Pancreatitis presumed to be related to: gallstones, medication, trauma, autoimmune pancreatitis, post-ERCP pancreatitis, pancreatic ductal adenocarcinoma, suspected cystic neoplasm, neuroendocrine tumors, and other uncommon tumors.
- Episode of acute pancreatitis requiring hospitalization in the past 4 weeks.
- Current medical or psychiatric illnesses that in the investigator's opinion would compromise their ability to tolerate study procedures.
- Currently incarcerated.
- Known pregnancy.
Trial locations and contacts
1 site in 1 country.
Felicity Pendergast, PhD contact
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Christie Jeon, PhD, 310-423-6345, Christie.Jeon@cshs.org
Christie Jeon, PhD
About this study
Official title: Application of a Wearable Alcohol Sensor for Prevention of Pancreatitis
The purpose the research is to demonstrate the feasibility of using a transdermal alcohol sensing device (BACtrack Skyn), and to correlate biological and self-reported alcohol measures with the transdermal alcohol measures in patients with a history of pancreatitis. The results from this study will inform tailored, self-directed interventions for reducing alcohol consumption in persons with pancreatitis.
Read the detailed description
Alcohol is the leading cause of recurrent acute and chronic pancreatitis, which greatly elevates the risk of pancreatic cancer. Reducing alcohol intake in patients with a history of alcoholic pancreatitis prevents progression of pancreatitis. Provider-based education on alcohol reduction has not translated to sustainable behaviors change, and more effective and scalable interventions are needed. Wearable alcohol sensors can empower patient-directed behavior change through real-time feedback on alcohol levels in the blood. BACtrack Skyn, the winner of NIAAA's Wearable Alcohol Biosensor Challenge, is a validated transdermal alcohol sensor that estimates blood alcohol concentration. In this pilot study, the investigators aim to (a) determine the feasibility and acceptability of using BACtrack Skyn to monitor changes in blood alcohol concentration among patients at risk for pancreatitis, (b) assess correlations between alcohol levels measured with BACtrack Skyn, breathalyzer, patient-reported alcohol consumption, and urine alcohol metabolite levels, (c) explore whether the use of a wearable alcohol sensor results in a decrease in alcohol consumption over a two-week period. Sixteen participants with known history of alcoholic pancreatitis will be assigned to wearing BACtrack Skyn for 2 weeks with the goal of not exceeding a blood alcohol concentration of 0.08%. Patient-reported drinking history, urine will be collected to correlate reported drinking levels and alcohol metabolic levels with the blood alcohol concentration readings in BACtrack Skyn. Findings from this study will be used as preliminary data to support and optimize subsequent grant applications and inform larger, randomized trials. The proposed study aligns closely with the mission of Cedars-Sinai and contributes to the growing body of research focusing on novel technologies for cancer prevention and control, as well as translational studies on alcoholic gastrointestinal diseases.
- Conditions
- Pancreatitis, Alcohol Drinking
- Being tested
- Wearable alcohol sensor
- Keywords
- Wearable technology, Remote monitoring, Pancreatitis, Continuous alcohol monitoring
- Medical subject headings
- Pancreatitis, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable alcohol sensorOther
BACtrack Skyn, is a novel transdermal blood alcohol sensor developed by BACtrack, a company established for police-grade breathalyzers, and winner of the Wearable Alcohol Biosensor Challenge sponsored National Institute on Alcohol Abuse and Alcoholism.
| Study group | Role | What they receive |
|---|---|---|
| Continuous alcohol monitoring | Wearable BACtrack Skyn device Receives: Other: Wearable alcohol sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of enrolled patients who wore the BACTrack sensor for at least 7 days within the 14-day period
Feasibility based on proportion of patients who wore the BACTrack sensor for at least 50% of study duration
Measured: up to 14 days
Secondary outcomes (5)
Acceptability of the BACtrack Skyn using the System Usability Scale (SUS)
SUS is a 10 item questionnaire, with 5 Likert-type response options (range 1(strongly disagree) to 5 (strongly agree)). Sensors will be deemed acceptable if ≥75% of the study population report an acceptability score of 68 or greater
Measured: 14 days
Blood alcohol concentration (BACtrack breathalyzer)
Daily levels of estimated BAC using breathalyzer (continuous)
Measured: up to 14 days
Patient-reported alcohol consumption
Number of alcoholic beverages each day
Measured: up to 14 days
Urine alcohol consumption
Urine alcohol metabolite (ethyl glucuronide [EtG]) levels (continuous)
Measured: 14 days
Patient-reported pain
Daily visual analog scale (range 0(low)-10 (high))
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study startJun 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gillian Gresham, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350996
- Sponsor's protocol ID
- STUDY00000526
- Acronym
- CAMP
- Status last verified
- Apr 2020
- First submitted
- 15 Apr 2020
- Last updated
- 29 Apr 2020
- 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 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of a Wearable Alcohol Sensor for Prevention of Pancreatitis
- ClinicalTrials.gov ID
- NCT04350996
- Acronym / sponsor ID
- CAMP / STUDY00000526
- Conditions
- Pancreatitis, Alcohol Drinking
- Keywords
- Wearable technology, Remote monitoring, Pancreatitis, Continuous alcohol monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 17 Apr 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.
The purpose the research is to demonstrate the feasibility of using a transdermal alcohol sensing device (BACtrack Skyn), and to correlate biological and self-reported alcohol measures with the transdermal alcohol measures in patients with a history of pancreatitis. The results from this study will inform tailored, self-directed interventions for reducing alcohol consumption in persons with pancreatitis.
Detailed description
Alcohol is the leading cause of recurrent acute and chronic pancreatitis, which greatly elevates the risk of pancreatic cancer. Reducing alcohol intake in patients with a history of alcoholic pancreatitis prevents progression of pancreatitis. Provider-based education on alcohol reduction has not translated to sustainable behaviors change, and more effective and scalable interventions are needed. Wearable alcohol sensors can empower patient-directed behavior change through real-time feedback on alcohol levels in the blood. BACtrack Skyn, the winner of NIAAA's Wearable Alcohol Biosensor Challenge, is a validated transdermal alcohol sensor that estimates blood alcohol concentration. In this pilot study, the investigators aim to (a) determine the feasibility and acceptability of using BACtrack Skyn to monitor changes in blood alcohol concentration among patients at risk for pancreatitis, (b) assess correlations between alcohol levels measured with BACtrack Skyn, breathalyzer, patient-reported alcohol consumption, and urine alcohol metabolite levels, (c) explore whether the use of a wearable alcohol sensor results in a decrease in alcohol consumption over a two-week period. Sixteen participants with known history of alcoholic pancreatitis will be assigned to wearing BACtrack Skyn for 2 weeks with the goal of not exceeding a blood alcohol concentration of 0.08%. Patient-reported drinking history, urine will be collected to correlate reported drinking levels and alcohol metabolic levels with the blood alcohol concentration readings in BACtrack Skyn. Findings from this study will be used as preliminary data to support and optimize subsequent grant applications and inform larger, randomized trials. The proposed study aligns closely with the mission of Cedars-Sinai and contributes to the growing body of research focusing on novel technologies for cancer prevention and control, as well as translational studies on alcoholic gastrointestinal diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuous alcohol monitoring | – | Other: Wearable alcohol sensorWearable BACtrack Skyn device |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients will have acute or chronic pancreatitis without calcification and have alcohol consumption score of ≥ 3 as measured using the validated TWEAK scale.
Key inclusion criteria (6 listed)
- Aged 18-75 years at the time of eligibility assessment
- History of at least one AP per Revised Atlanta Classification (20) within past 3 years from screening, which requires two of the following evidence of pancreatitis:
- Abdominal pain consistent with AP (acute onset of a persistent, severe, epigastric pain often radiating to the back)
- Serum lipase activity (or amylase activity) at least three times greater than the upper limit of normal
- Characteristic findings of AP on contrast-enhanced computed tomography (CECT), magnetic resonance imaging (MRI) or transabdominal ultrasonography
Key exclusion criteria (5 listed)
- Pancreatitis presumed to be related to: gallstones, medication, trauma, autoimmune pancreatitis, post-ERCP pancreatitis, pancreatic ductal adenocarcinoma, suspected cystic neoplasm, neuroendocrine tumors, and other uncommon tumors.
- Episode of acute pancreatitis requiring hospitalization in the past 4 weeks.
- Current medical or psychiatric illnesses that in the investigator's opinion would compromise their ability to tolerate study procedures.
- Currently incarcerated.
- Known pregnancy.
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 |
|---|---|---|
| Wearable alcohol sensorBACtrack Skyn, is a novel transdermal blood alcohol sensor developed by BACtrack, a company established for police-grade breathalyzers, and winner of the Wearable Alcohol Biosensor Challenge sponsored National Institute on Alcohol Abuse and Alcoholism. | Other | Continuous alcohol monitoring |
Primary outcome
Proportion of enrolled patients who wore the BACTrack sensor for at least 7 days within the 14-day period
Time frame: up to 14 days
Feasibility based on proportion of patients who wore the BACTrack sensor for at least 50% of study duration
5 secondary outcomes
Acceptability of the BACtrack Skyn using the System Usability Scale (SUS)
Time frame: 14 days
Blood alcohol concentration (BACtrack breathalyzer)
Time frame: up to 14 days
Patient-reported alcohol consumption
Time frame: up to 14 days
Urine alcohol consumption
Time frame: 14 days
Patient-reported pain
Time frame: up to 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Felicity Pendergast, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatitis and Alcohol Drinking, run by Cedars-Sinai Medical Center at 1 site in United States.
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 5 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 29 Apr 2020. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gillian Gresham Gresham, PhD (410-323-3341, gillian.gresham@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of enrolled patients who wore the BACTrack sensor for at least 7 days within the 14-day period (time frame: up to 14 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 29 Apr 2020.