Pilot Study Roadmap
PancreaTrack's proposed framework for a prospective observational pilot study to validate patient-generated health data as a clinical instrument in chronic pancreatic disease.
PancreaTrack has not yet launched a formal clinical study. This page describes the study design we intend to pursue pending IRB approval and institutional partnership. See Partnership Opportunities if you are interested in collaborating.
Study Overview
| Parameter | Detail |
|---|---|
| Study type | Prospective observational, single-arm |
| Target conditions | Chronic pancreatitis, EPI on PERT, post-TPIAT |
| Target enrollment | 50–100 patients across 2–3 clinical sites |
| Study duration | 6 months per patient |
| Primary endpoint | Feasibility: ≥70% logging adherence over 6 months |
| Secondary endpoints | PERT dose correlation with stool outcomes; pain trend detection; physician-rated summary utility |
| IRB requirement | Yes — full board review required prior to enrollment |
| Data handling | Per PancreaTrack privacy policy; de-identified export for analysis |
Inclusion Criteria (Proposed)
- Age ≥ 18
- Confirmed diagnosis of one of: chronic pancreatitis, exocrine pancreatic insufficiency, or post-TPIAT status
- Currently managed by a participating gastroenterologist or surgeon
- Access to a smartphone or computer for daily logging
- Able to provide informed consent
- English language (initial cohort; Spanish language support planned)
Exclusion Criteria (Proposed)
- Active pancreatic malignancy
- Acute pancreatitis requiring hospitalization within 30 days of enrollment
- Inability to perform self-reported logging due to cognitive or physical impairment
- Enrolled in a concurrent interventional clinical trial that prohibits observational participation
Study Timeline
Draft protocol, consent forms, and data use agreement. Submit for IRB review at primary institution. Execute Business Associate Agreements with participating sites.
Enroll first 20 patients at lead site. Assess onboarding completion rate, early logging adherence, and usability issues. Refine onboarding workflow based on feedback.
Open enrollment at additional sites. Reach target N of 50–100. Maintain 6-month follow-up window per patient.
De-identify and export data. Analyze primary and secondary endpoints. Draft manuscript for peer-reviewed submission. Present at Digestive Disease Week or similar venue.
Physician Component
Participating physicians will be asked to:
- Link to enrolled patients in the Physician Portal
- Review PancreaTrack AI-generated summaries prior to scheduled appointments
- Complete a brief structured survey after each appointment (estimated 3 minutes) rating summary utility and documenting any treatment adjustments made
- Participate in a semi-structured interview at study end (approximately 20 minutes)
IRB and Regulatory Considerations
PancreaTrack is not currently a HIPAA-compliant Business Associate. Institutional partners should review the HIPAA Roadmap. The planned Q4 2026 BAA execution will be a prerequisite for formal IRB submission at HIPAA-covered institutions.
- Data classification: Patient-generated health data (not EHR-derived); no PHI transmitted to AI without de-identification
- Consent model: Separate study consent in addition to PancreaTrack Terms of Service
- Withdrawal: Patients may withdraw at any time; data collected prior to withdrawal may be retained per consent form language
- Adverse event reporting: Not applicable (observational only; no intervention)
Funding Targets
PancreaTrack is actively seeking funding to support this pilot through:
- NIH SBIR Phase I — PA-24-211 (Small Business Innovation Research, digital health focus)
- Patient advocacy grants — National Pancreas Foundation, NIDDK-supported initiatives
- Industry partnerships — PERT manufacturers with interest in real-world dosing outcomes data
- Institutional collaborations — Co-investigator grants with academic medical centers housing pancreatic disease programs