CLINICAL EVIDENCE
Validated in practice.
Not just theory.
Demonstrated in clinical procedures, anchored by a peer-reviewed, published study of 125 consecutive patients. Designed to address the limitations of traditional at-home prep.
CLINICAL VALIDATION
Peer-reviewed. Published. Validated across real-world international procedures.
Colonoscopy Without Early Preparation (CWEP)
A retrospective clinical study of clinic-based warm-water bowel preparation
PROCEDURES
500+ published study of first 125
SETTING
SUPERVISED CLINICAL
OUTCOME SCALE
Four-tier grading scale
ADVERSE AFFECTS
No device-related serious adverse events reported
89.4%
Excellent or good prep qualitY¹
98.4%
PATIENT COMPLETION RATE²
1.6%
Reported mild side effects in published clinical study³
100%
PREFERRED ZERAFLOW OVER PRIOR ORAL PREP EXPERIENCE⁴
CATEGORY CONTEXT
The science ZeraFlow builds on
Why clinic-based warm-water preparation addresses the limitations of oral prep
Independent clinical research consistently demonstrates that supervised, clinic-based warm-water bowel preparation is designed to achieve consistently high adequacy rates by removing the compliance variable inherent in 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.⁵⁵
The scale of the oral prep failure problem
Across published real-world studies, up to 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 adenoma detection rates reduced by up to 47% in poorly prepped colons.⁶
WHAT COMES NEXT
International validation complete. U.S. pilot next.
COMPLETE
International clinical study
COMPLETE
Peer-reviewed publication
IN PROGRESS
FDA 510(k) Submission in June 2026
UPCOMING
Pilot in 1-3 US locations
UPCOMING
U.S. publication and scale
NEXT MILESTONE
U.S. Clinical Pilot — Post FDA
Following FDA, Zera Medical will conduct a structured U.S. clinical pilot across one to three 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
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.
The ZeraFlow Colon Irrigation Kit is intended for mechanical cleansing of the colon when medically indicated, such as before radiological or endoscopic examination. The device is intended for prescription use only.
¹ Ziv Y, Scapa E. Techniques in Coloproctology. 2013;17:39–44. https://link.springer.com/article/10.1007/s10151-012-0876-8
² Ziv Y, Scapa E. Techniques in Coloproctology. 2013;17:39–44. https://link.springer.com/article/10.1007/s10151-012-0876-8
³ Mild transient nausea reported in 1.6% of patients (n=2 of 125). No abdominal pain, cramping, or post-colonoscopy diarrhea reported. Source: Ziv Y, Scapa E. Techniques in Coloproctology. 2013;17:39–44. https://link.springer.com/article/10.1007/s10151-012-0876-8
⁴ Ziv Y, Scapa E. Techniques in Coloproctology. 2013;17:39–44. Preference data from subset of patients with prior colonoscopy experience. https://link.springer.com/article/10.1007/s10151-012-0876-8
⁵ Ziv Y, Scapa E. Techniques in Coloproctology. 2013;17:39–44. https://link.springer.com/article/10.1007/s10151-012-0876-8
⁶ Ness RM et al. Am J Gastroenterol. 2001;96:1797–1802. https://pubmed.ncbi.nlm.nih.gov/11419832/ Hassan C et al. PLOS ONE. 2016;11(1):e0147981. https://pmc.ncbi.nlm.nih.gov/articles/PMC8082895/