Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202111738348757 Date of Registration: 10/11/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Validation of Chloe SED, a reusable, low-cost syringe extension device for the provision of paracervical analgesia during gynecologic procedures
Official scientific title Validation of Chloe SED, a reusable, low-cost syringe extension device for the provision of paracervical analgesia during gynecologic procedures
Brief summary describing the background and objectives of the trial Chloe SED (Syringe Extension Device) is a new medical device, when attached to a syringe, it provides the additional length required to allow for the injection of hard to reach areas with a standard syringe and needle. This precludes the need to use a spinal needle. It therefore lends itself for the issuance of para-cervical block during manual vacuum aspiration (MVA), being a reusable plastic device, it is a cheap alternative to spinal needles. The objective of this trial is to validate the Chloe SED, by demonstrating non inferiority in pain scores of patients who undergo MVA with the Chloe SED compared to the standard spinal needle.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Incomplete Miscarriage
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/12/2021
Actual trial start date 02/05/2022
Anticipated date of last follow up 29/09/2023
Actual Last follow-up date 30/10/2024
Anticipated target sample size (number of participants) 210
Actual target sample size (number of participants) 210
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
37914 Grand Challenges Canda
48521 JARAMOGI OGINGA ODINGA TEACHING AND REFERRAL HOSPITAL
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group SPINAL NEEDLE STAT Spinal needle is the needle used for lumbar puncture for collection of a spinal tap, or for administration of spinal anaesthesia 105 Active-Treatment of Control Group
Experimental Group CHLOE SED STAT This is a novel medical device, which when attached to a 10 cc syringe provides additional length required for an injection, thereby obviating the need of a spinal needle 105
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
● Women’s health providers providing MVA services. ● Female patients receiving MVA at the two study sites. These women will be determined clinically eligible for MVA treatment by a icensed Kenyan Medical Officer or Clinical Officer who has evaluated them. ● Ability to consent and understand that participation in the study involves potential use of a new device during the planned MVA. ● Age 18 years or greater. • Males will be excluded from the patient population as men do not receive MVA services. Male MVA providers will not be excluded from the provider population. • All persons under the age of 18 will be excluded. • Any member of the research team (including PI and Co-Is) who is also a women’s health provider will be excluded so as to avoid bias. • There is no exclusion based on race, tribe, religion or sexual orientation in the study for any patients or providers who meet inclusion criteria. There are no exclusions for patients based on language. • Contraindications to lidocaine or patients with increased risks to MVA procedure (as determined by PPB in the initial pilot study) which include the following:  Known or suspected hypersensitivity to lidocaine  Skin infection adjacent to proposed site of injection (for MVA this would include uterine and cervical infection)  Concomitant anticoagulant therapy or an abnormal bleeding tendency  Severe anemia or heart disease. Severe anemia will be defined as per the WHO, as anemia associated with symptoms of fatigue, weakness, dizziness, and drowsiness or known haemoglobin concentration less than 7.0 g/dL Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/08/2021 JOOTRH IERC
Ethics Committee Address
Street address City Postal code Country
Kisumu to Kakamega highway Kisumu 849 - 401 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/04/2022 Pharmacy and Poisons Board Kenya
Ethics Committee Address
Street address City Postal code Country
PHARMACY AND POISONS BOARD HOUSE - LENANA ROAD NAIROBI 00506 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain scores on the Numerical Rating Scale - NRS scale At insertion of speculum, during insertion of speculum, during application of block, during uterine suction and 30 minutes after procedure
Secondary Outcome Patient experiences and preferences during MVA At the end of the trial
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Jaramogi Oginga Odinga Teaching and Referral Hospital Kisumu to Kakamega Highway Kisumu Kenya
Kisii Teaching and Referral Hospital Kisii Town Kisii Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Grand Challenges Canada 661 University Avenue, Suite 1720 Toronto Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nyanza Reproductive Health Society Lumumba Hospital Kisumu Kenya Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Stephen Gwer gwerso@gmail.com +254722657163 Wathorego Disciples of Mercy
City Postal code Country Position/Affiliation
Kisumu Kenya Associate Research Scientist
Role Name Email Phone Street address
Scientific Enquiries Aparna Ramanathan aparna.rajam@gmail.com +16173888643 National Center for Advanced Pelvic Surgery, Medstar Washington Hospital Center, Georgetown University,
City Postal code Country Position/Affiliation
Washington United States of America Associate Proffessor
Role Name Email Phone Street address
Public Enquiries Robert Bailey rcbailey@uic.edu +13129966620 University of Illinois at Chicago 820 South Wood Street
City Postal code Country Position/Affiliation
Chicago United States of America Proffessor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Yes. We will share the participant data that supports the results obtained after deidentification Clinical Study Report,Statistical Analysis Plan,Study Protocol Data will be available 3 months after publication and without an end date This data will be open access, for anyone who wishes to achieve the aims in the initial protocol and for individual participant metaanalysis a link will be provided to access the data.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 14/02/2026
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 14/02/2026
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 22/09/2024 We got final approval on 29th April 02 May 2022
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 22/09/2024 This was the actual date of recruitment of the last provider 31 Jul 2022 29 Sep 2023
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 22/09/2024 Data analysis is still ongoing. 30 Oct 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 22/09/2024 Not changed 210
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 22/09/2024 We have completed patient follow up and data analysis is ongoing. Not yet recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 10/11/2021 PACTR update Adult: 19 Year-44 Year Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 27/05/2026 PACTR Admin Adolescent: 13 Year(s)-17 Year(s), Adult: 18 Year(s)-44 Year(s), Middle Aged: 45 Year(s)-64 Year(s) Adult: 18 Year(s)-44 Year(s), Middle Aged: 45 Year(s)-64 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 22/09/2024 This is the correct terminology of the scale used Primary Outcome, Pain scores on the VAS scale, At insertion of speculum, during insertion of speculum, during application of block, during uterine suction and 30 minutes after procedure Primary Outcome, Pain scores on the Numerical Rating Scale - NRS scale, At insertion of speculum, during insertion of speculum, during application of block, during uterine suction and 30 minutes after procedure
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 22/09/2024 This was a secondary approval after the JOOTRH approval TRUE, Pharmacy and Poisons Board Kenya, PHARMACY AND POISONS BOARD HOUSE - LENANA ROAD, NAIROBI, 00506, Kenya, , 29 Apr 2022, +254733884411, practice@ppb.go.ke, 18224_30030_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 22/09/2024 Change of employment and migration to new city Scientific Enquiries, Aparna, Ramanathan, Dr., aparna.rajam@gmail.com, aparna3@uic.edu, +16173888643, University of Illinois at Chicago 820 South Wood Street, Chicago, , United States of America, Associate Proffessor Scientific Enquiries, Aparna, Ramanathan, Dr., aparna.rajam@gmail.com, , +16173888643, National Center for Advanced Pelvic Surgery, Medstar Washington Hospital Center, Georgetown University,, Washington, , United States of America, Associate Proffessor
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 14/02/2026 Results are now available No Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file1 14/02/2026 Quantitative Results being uploaded 18224_12263_1045.pdf