CLINICAL EVIDENCE

The evidence is real.
The outcomes speak.

ZeraFlow has been validated in more than 500 real-world clinical procedures, demonstrating outcomes that materially outperform traditional at-home oral bowel preparation. The foundational study has been peer-reviewed and published.

CLINICAL VALIDATION

Peer-reviewed. Published. 500+ procedures.

Colonoscopy Without Early Preparation (CWEP)
A retrospective clinical study of clinic-based warm-water bowel preparation

PROCEDURES

500+

SETTING

SUPERVISED CLINICAL

OUTCOME SCALE

BOSTON BBPS

ADVERSE AFFECTS

ZERO SERIOUS

97%

ADEQUATE OR
BETTER PREP

98.4%

PATIENT
COMPLETION RATE

100%

PREFERRED OVER
PRIOR ORAL PREP

100%

PATIENT
SATISFACTION

Ziv Y, Scapa E. A new colonic lavage system to prepare the colon for colonoscopy: a retrospective study. Techniques in Coloproctology. 2013;17:39–44.

View Publication

CATEGORY CONTEXT

The science ZeraFlow builds on

Why clinic-based warm-water preparation outperforms oral prep

Independent clinical research consistently demonstrates that supervised, clinic-based warm-water bowel preparation achieves adequacy rates significantly exceeding those of at-home oral regimens. The core advantage is control: removing preparation from an uncontrolled home environment and placing it in a standardized clinical workflow eliminates the patient compliance variable that drives most oral prep failures.

Ziv Y, Scapa E. Techniques in Coloproctology. 2013;17:39–44.

The scale of the oral prep failure problem

Across published real-world studies, 18–35% of colonoscopies are performed with inadequate or suboptimal bowel preparation. Inadequate prep directly degrades visualization, increases procedure time, and raises the risk of missed pathology — with polyp miss rates as high as 42–48% in poorly prepped colons.

Bucci C et al. World Journal of Gastroenterology. 2014. van Rijn JC et al. American Journal of Gastroenterology. 2006.

WHAT COMES NEXT

International validation complete. U.S. pilot next.

COMPLETE

International clinical study

COMPLETE

Peer-reviewed publication

IN PROGRESS

FDA 510(k) clearance

UPCOMING

U.S. clinical pilot (~1,000)

UPCOMING

U.S. publication and scale

NEXT MILESTONE

U.S. Clinical Pilot — Post FDA Clearance

Following FDA clearance, Zera Medical will conduct a structured U.S. clinical pilot across one to three flagship GI practices and ASCs, enrolling approximately 1,000 procedures. Results will be prepared for peer-reviewed publication.

TARGET ENROLLMENT

~1,000 PROCEDURES

PRIMARY ENDPOINT

BBPS ADEQUACY RATE