CLINICAL EVIDENCE

Proven in practice.
Not just theory.

Validated in 500+ real-world clinical procedures, including results from a peer-reviewed, published study of the first 125 consecutive patients.¹ Outperforms traditional at-home prep.

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 Bowel Preparation Scale (BBPS)

ADVERSE AFFECTS

ZERO SERIOUS

96.3%

ADEQUATE OR BETTER PREP²

98.4%

PATIENT COMPLETION RATE³

100%

PATIENT SATISFACTION⁴

100%

PREFERRED OVER PRIOR ORAL PREP⁵

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

SECONDARY ENDPOINTS

SAFETY, SATISFACTION, EFFICIENCY

PUBLICATION PLAN

PEER-REVIEWED JOURNAL

Medical Advisory Board

Ready to learn more or become a pilot site?

Bring ZeraFlow to your practice. Join our U.S. pilot program or connect with our team to learn more.

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Contact the Team 
¹ Ziv Y, Scapa E. Techniques in Coloproctology. 2013;17:39–44. DOI: 10.1007/s10151-012-0876-8. 
² ³ ⁴ ⁵ Ziv Y, Scapa E. Techniques in Coloproctology. 2013;17:39–44. DOI: 10.1007/s10151-012-0876-8.
ZeraFlow is an investigational device. It has not been cleared or approved by the U.S. FDA and is not currently available for commercial sale in the United States.