--- title: "Sham Control, Definition | MedTech Terms" description: "Placebo-equivalent for device trials - a non-therapeutic procedure that mimics the investigational intervention." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/sham-control#term", "name": "Sham Control", "description": "Sham controls are used when blinding is feasible (e.g., neurostimulator off-state, sham endoscopic procedures) and ethical, providing the strongest control against placebo effects.", "url": "https://medtechterms.com/terms/sham-control", "termCode": "sham-control", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/sham-control#article", "headline": "Sham Control", "description": "Placebo-equivalent for device trials - a non-therapeutic procedure that mimics the investigational intervention.", "url": "https://medtechterms.com/terms/sham-control", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/sham-control" }, "about": { "@id": "https://medtechterms.com/terms/sham-control#term" }, "articleSection": "Clinical & Trials", "inLanguage": "en", "keywords": "Sham Control, Clinical & Trials, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-05-05", "dateModified": "2026-05-05", "citation": [ { "@type": "CreativeWork", "name": "FDA Sham Control Guidance", "url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents", "publisher": { "@type": "Organization", "name": "FDA" } }, { "@type": "CreativeWork", "name": "ICH Guidelines", "url": "https://www.ich.org/page/ich-guidelines", "publisher": { "@type": "Organization", "name": "ICH" } }, { "@type": "CreativeWork", "name": "ISO 14155 Standard Page", "url": "https://www.iso.org/standard/71690.html", "publisher": { "@type": "Organization", "name": "ISO" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/blinding#term", "name": "Blinding and Masking", "url": "https://medtechterms.com/terms/blinding" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/pivotal-trial#term", "name": "Pivotal Trial", "url": "https://medtechterms.com/terms/pivotal-trial" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Clinical & Trials", "item": "https://medtechterms.com/terms?cat=Clinical%20%26%20Trials" }, { "@type": "ListItem", "position": 4, "name": "Sham Control", "item": "https://medtechterms.com/terms/sham-control" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/sham-control#faq", "mainEntity": [ { "@type": "Question", "name": "What is the primary purpose of a sham control in a clinical trial?", "acceptedAnswer": { "@type": "Answer", "text": "The primary purpose is to control for the placebo effect and other non-specific effects, providing a clearer understanding of the device's true therapeutic benefit." } }, { "@type": "Question", "name": "When are sham controls typically used?", "acceptedAnswer": { "@type": "Answer", "text": "Sham controls are used when blinding is feasible and ethical, and when there is a need to distinguish the device's specific effect from patient expectations or other confounding factors." } }, { "@type": "Question", "name": "What ethical considerations are involved in using sham controls?", "acceptedAnswer": { "@type": "Answer", "text": "Ethical considerations include ensuring patient safety, informed consent that clearly explains the possibility of receiving a sham, and careful justification for withholding active treatment." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Clinical & Trials](/terms?cat=Clinical%20%26%20Trials) 6. / 7. Sham Control [All terms](/terms) Clinical & Trials [Clinical Evidence](/ecosystems/clinical-evidence) # Sham Control Placebo-equivalent for device trials - a non-therapeutic procedure that mimics the investigational intervention. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Sham controls are used when blinding is feasible (e.g., neurostimulator off-state, sham endoscopic procedures) and ethical, providing the strongest control against placebo effects. What the regulation says Regulatory bodies like the FDA recognize sham controls as a robust method for evaluating medical devices, especially when blinding is achievable and ethically sound. The FDA guidance "Considerations for the Design and Conduct of Externally Controlled Trials of Medical Devices" discusses the appropriate use of controls, including sham controls, to minimize bias and demonstrate device effectiveness. Similarly, [ISO 14155](/terms/iso-14155), Clinical investigation of medical devices for human subjects - [Good clinical practice](/terms/gcp), outlines principles for clinical investigations, including control group selection, to ensure scientific validity and protect subjects. ## What this means in practice Sham-controlled device trials raise ethics, [IRB](/terms/irb), and patient acceptance challenges; FDA has issued specific guidance on appropriate use. ## Examples - A trial for a novel pain relief device might use a sham control device that looks identical but delivers no therapeutic energy. - In a study of a surgical implant, the sham control group might undergo a similar surgical procedure without the actual active implant. - A clinical investigation for an ophthalmic device may involve a sham procedure where patients receive an inactive intervention that mimics the active treatment. Common pitfalls - • Sham controls must be ethically justifiable, ensuring that withholding the active treatment does not pose undue risk to participants. - • Designing an effective sham control requires careful consideration to ensure it truly mimics the active intervention without providing therapeutic benefit. - • Patient recruitment can be challenging in trials utilizing sham controls due to the potential for participants to receive a non-therapeutic intervention. - • Failing to adequately blind participants or investigators to the sham control can introduce bias and compromise the study results. ## Frequently asked questions What is the primary purpose of a sham control in a clinical trial? The primary purpose is to control for the placebo effect and other non-specific effects, providing a clearer understanding of the device's true therapeutic benefit. When are sham controls typically used? What ethical considerations are involved in using sham controls? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Clinical & Trials Blinding and Masking Procedures that hide treatment assignment from patients, investigators, or assessors to reduce bias. ](/terms/blinding)[ Clinical & Trials Pivotal Trial Definitive clinical study designed to establish safety and effectiveness for marketing authorization. ](/terms/pivotal-trial) ### More in Clinical & Trials · Same category [ Clinical & Trials Adaptive Trial Design Trial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data. ](/terms/adaptive-trial)[ Clinical & Trials Adverse Event(AE) Any untoward medical occurrence in a subject, whether or not related to the device. ](/terms/adverse-event)[ Clinical & Trials ALCOA+ Data integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate (plus Complete, Consistent, Enduring, Available). ](/terms/alcoa-plus)[ Clinical & Trials Analytical Sensitivity An IVD's ability to detect small quantities of an analyte. ](/terms/analytical-sensitivity) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Clinical Evidence](/ecosystems/clinical-evidence) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 1 ICH· 1 ISO· 1 1. [1 FDA Sham Control Guidance Verified FDA · fda.gov ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents) 2. [2 ICH Guidelines Verified ICH · ich.org ](https://www.ich.org/page/ich-guidelines) 3. [3 ISO 14155 Standard Page Verified ISO · iso.org ](https://www.iso.org/standard/71690.html) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Clinical evidence intersecting with device security? We support clinical-stage MedTech teams whose investigational devices touch patient data or hospital networks. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Clinical & Trials Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=sham-control) Learn in 60 seconds Card Lesson Quiz Placebo-equivalent for device trials - a non-therapeutic procedure that mimics the investigational intervention. - · Sham-controlled device trials raise ethics, IRB, and patient acceptance challenges; FDA has issued specific guidance on appropriate use. Remember this Watch out: Sham controls must be ethically justifiable, ensuring that withholding the active treatment does not pose undue risk to participants. Related terms - [Blinding and Masking ](/terms/blinding) - [Pivotal Trial ](/terms/pivotal-trial) You may also need Auto-suggested from Clinical & Trials and shared keywords. - [Non-Inferiority Trial ](/terms/non-inferiority-trial) - [Master Protocol (Basket / Umbrella / Platform) ](/terms/master-protocol) - [Brainjacking ](/terms/brainjacking) - [Bayesian Trial Design ](/terms/bayesian-trial) - [Feasibility Study ](/terms/feasibility-study) - [Investigator Brochure(IB) ](/terms/investigator-brochure) [All Clinical & Trials terms](/terms?cat=Clinical%20%26%20Trials) From the Blue Goat network Related resources and services on this topic. - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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