Capturing Intra-Operative Bleeding Endpoints Across a 10-Site Surgical Hemostat Trial with Clinion EDC
Overview
In surgical hemostat trials, the most important endpoint data is generated inside the operating room. This Phase III medical device study evaluated an absorbable hemostat powder against an active comparator in patients with mild or moderate soft tissue or parenchymal bleeding during general surgery.
The study’s primary endpoint focused on hemostatic success at 5 minutes after powder application, with additional assessments at 3 and 10 minutes. This made intra-operative data capture highly time-sensitive, as each site had to record the target bleeding site, device application, bleeding control, re-bleeding status, and any additional treatment required during the procedure. The public registry describes the study as a prospective, randomized, active-controlled, observer-blind, multicenter medical device trial conducted in India.
Clinion EDC supported structured capture of surgical endpoint data across 10 participating sites. The platform helped the sponsor manage procedure-specific data, endpoint timing, safety information, and site-level review within one controlled EDC workflow.
Study Snapshot
Industry
Biotech
Client
Medical device sponsor
Study Type
Interventional
Therapeutic Area
Surgical Hemostasis
Study Phase
Phase III
Study Design
Prospective, randomized, active-controlled, observer-blind, multicenter device trial
Randomization
Single blind / outcome assessor blinded
Region
India
Site Count
10 sites
Submission
DCGI regulatory
Study Duration
9 months, per registry record and project input
Products Provided
Challenges
Capturing Time-Critical Surgical Endpoints Across 10 Sites
The key endpoint was observed during surgery after the hemostat powder was applied. The challenge was making sure every site documented the same required details clearly, including the target bleeding site, hemostatic outcome, re-bleeding, and any additional treatment.
01
Documenting Hemostatic Success in a Consistent Format
The trial assessed hemostatic success at defined intra-operative timepoints after powder application. Since the outcome was observed by the surgical team during the procedure, the challenge was ensuring that each site recorded the result clearly, with the required fields completed for review.
02
Keeping Target Bleeding Site Details Linked to the Endpoint
Each subject had a target bleeding site identified during surgery. The sponsor needed the bleeding site details, device application, hemostatic outcome, re-bleeding status, and additional treatment information to stay connected within the same subject record, rather than being captured as separate notes.
03
Standardizing Data Capture Across Surgical Sites
The study involved 10 surgical centers, different procedure settings, and multiple site teams. The challenge was keeping surgeon-recorded endpoint data consistent across sites, so the sponsor could review comparable data without excessive manual reconciliation.
Solutions
A Structured Clinion EDC Workflow for Surgical Data Capture
Clinion EDC was configured to help sites document surgeon-observed endpoint data in a consistent structure. The platform supported protocol-defined timepoint fields, procedure-specific records, and centralized review across the 10-site surgical network. .
Outcomes
Core Results
Clinion EDC helped the sponsor manage a time-critical surgical device trial with stronger consistency across endpoint capture, group-level data, and multisite review.
Intra-Operative Data Precision
Timepoint-based eCRFs helped capture hemostatic success data consistently.
Group-Level Data Clarity
Structured capture helped keep device group and surgery-type data organized.
Multisite Surgical Consistency
A shared EDC workflow helped 10 sites capture surgical trial data consistently.
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Compliance
Fully Compliant with Global Standards
