Manual PressureNCT06496958
Water Exchange and CO2 Insufflation With Abdominal Compression Device to Reduce Manual Assistance
A study testing CO2 insufflation with an abdominal compression device and Water exchange colonoscopy in people with Manual Pressure and Repositioning, run by Evergreen General Hospital, Taiwan at 2 sites in Taiwan.
Trial summary
The goal of this trial is to evaluate whether water exchange colonoscopy and CO2-insufflation colonoscopy with an abdominal compression device (Maxbelt me3 type, Nippon Sigmax Co., Tokyo, Japan) can achieve a significantly lower proportion of patients requiring manual abdominal pressure during colonoscopic insertion… Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Manual Pressure, Repositioning, Colonoscopy
- What is being tested?
- CO2 insufflation with an abdominal compression device and Water exchange colonoscopy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 2 sitesTaiwan
- Study dates
- 2 Sep 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 45-80 years having an average risk for colorectal cancer who plan to undergo sedated outpatient colonoscopy for screening, surveillance, and those who have received a positive fecal immunochemical test result
Who cannot join
- Patients with hereditary colorectal cancer syndrome, including familial adenomatous polyposis and hereditary nonpolyposis colorectal cancer (Lynch syndrome)
- Patients with serrated polyposis syndrome
- Patients with known or suspected inflammatory bowel disease
- Patients with a history of colorectal cancer or other intra-abdominal malignancy
- Patients with a history of colorectal resection
- Patients with a history of abdominal aortic aneurysm, cirrhosis, ascites, or other severe comorbid illnesses
Show all 17Show fewer
- Patients with recent wounds or skin rash on the anterior abdominal wall and back
- Patients with known ventral hernia
- Patients with unsedated procedure
- Patients with planned bidirectional endoscopy
- Patients with body mass index >35 kg/m2
- Patients with waist circumference <55 cm or >105 cm
- Patients with known or suspected gastroparesis
- Patients with planned therapeutic procedures (e.g., hemostasis, removal of a large polyp)
- Patients with mental retardation
- Pregnant women or those planning pregnancy
- Patients unwilling to participate in the study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jen-Hao Yeh, MD contact
Taiwan2 sites, 2 recruiting
- Recruiting
E-Da Dachang Hospital
Kaohsiung City, 807
Jen-Hao Yeh, MD, 0912317799, b9202078@gmail.com
Jen-Hao Jeh, MD
- Recruiting
Evergreen General Hospital
Taoyuan, 320
Chi-Liang Cheng, MD, 0919768058, chiliang.cheng@gmail.com
Chi-Liang Cheng, MD
About this study
Official title: CO2 Insufflation Colonoscopy With an Abdominal Compression Device and Water Exchange Colonoscopy to Reduce Manual Assistance by Endoscopy Staff: A Multicenter Randomized Trial
The goal of this trial is to evaluate whether water exchange colonoscopy and CO2-insufflation colonoscopy with an abdominal compression device (Maxbelt me3 type, Nippon Sigmax Co., Tokyo, Japan) can achieve a significantly lower proportion of patients requiring manual abdominal pressure during colonoscopic insertion compared with CO2 insufflation alone.
Read the detailed description
This will be a three-arm multicenter parallel randomized controlled trial (RCT) designed to compare the frequency of ancillary manual assistance (abdominal pressure and/or position change) between CO2-insufflation colonoscopy with Maxbelt (intervention group), CO2-insufflation colonoscopy with sham device (sham control group), and water exchange (WE) colonoscopy (WE group). Enrolled patients will be randomized in a 1:1:1 ratio to either the intervention, sham control, or WE group. This will be a comparison of three different methods (CO2 with interventional device, CO2 with sham device, WE) to see which one is better at decreasing the need for manual assistance by endoscopy staff during colonoscopic insertion.
This study will be conducted in two hospitals in Taiwan: Evergreen General Hospital at Taoyuan and E-Da Dachange Hospital at Kaohsiung. The Sepulveda Ambulatory Care Center, VAGLAHS, UCLA in the USA will be a non-recruiting participating site. This planned RCT will span 30 months (from June 2024 to November 2026), including 3 months for the initial setup and 3 months for the final analysis. The study site possesses state-of-the-art colonoscopy equipment setups, and the investigators are WE colonoscopy research experts.
Patients aged 45-75 y/o at average risk of colorectal cancer who are willing to participate will sign an informed consent before starting the colonoscopy procedure. Separate parallel randomization will be set up at each site, stratified by investigator and type of colonoscopy (screening, surveillance, or positive fecal immunochemical test result). Mode of sedation will include conscious sedation (fentanyl plus midazolam) or full sedation (propofol with fentanyl plus midazolam) . Randomization will be carried out by computer-generated sequences using a block design (four participants per block).
CO2 with interventional device group: The Maxbelt will be applied around the circumference of the lower abdomen just below the umbilicus based on patient's abdominal circumference. Five sizes of Maxbelt will be employed in this study: XS-size for 55-65 cm circumference, S-size for 65-75 cm circumference, M-size for 75-85 cm circumference, L-size for 85-95 cm circumference, and XL-size for 95-105 cm circumference. Once applied, participants will be asked to assess and confirm that the belt is fastened tightly but not uncomfortably.
CO2 with sham device group: A two-size larger Maxbelt with loose fitting will be used as a sham device: L-size will be used for 55-71 cm circumference, XL-size will be used for 72-88 cm circumference, and 2 XL-size will be used for 89-105 cm circumference.
WE group: The air pump will be turned off during the insertion phase of colonoscopy, while the colon is irrigated with warm-to-touch distilled water or half normal saline using a flushing pump. The WE approach involves the simultaneous infusion of water to facilitate luminal expansion and suction of unclean water during insertion.
- Conditions
- Manual Pressure, Repositioning, Colonoscopy, Colon Polyp
- Being tested
- CO2 insufflation with an abdominal compression device, CO2 insufflation with a sham abdominal compression device, Water exchange colonoscopy
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 insufflation with an abdominal compression deviceDevice
For participants randomized to the intervention group, the back brace support belt, Maxbelt (me3 type, Nippon Sigmax Co., Tokyo, Japan), will be applied around the circumference of the lower abdomen. Five sizes of Maxbelt will be employed in this study. According to the manufacturer, the ultra small-size (XS-size) belt will be used in those patients with an abdominal circumference of 55 cm-65 cm, the small-size (S-size) belt will be used in those patients with an abdominal circumference of 65 cm-75 cm, the medium-size (M-size) belt will be used for a circumference of 75 cm-85 cm, the large-size (L-size) belt will be used for a circumference of 85 cm-95 cm, and the ultra large-size (XL-size) will be used for a circumference of 95 cm-105 cm. Once applied, participants will be asked to assess and confirm that the belt is fastened tightly but not uncomfortably.
CO2 insufflation with a sham abdominal compression deviceDevice
The study coordinator will fit the sham device in a private bay alone with the patient. For participants randomized to the sham control group, a larger-sized Maxbelt with loose fitting will be used as a sham device. The L-size Maxbelt will be used in those patients with an abdominal circumference of 55 cm-71 cm, the XL-size Maxbelt will be used in in those patients with an abdominal circumference of 72 cm-88 cm, and the 2 XL-size Maxbelt will be used in in those patients with abdominal circumference 89 cm-105 cm.
Water exchange colonoscopyDevice
In those patients assigned to the water exchange (WE) group, the air pump will be turned off during the insertion phase of colonoscopy, while the colon is irrigated with warm-to-touch distilled water or half normal saline using a flushing pump. The WE approach involves the simultaneous infusion of water to facilitate luminal expansion and suction of unclean water during insertion. Any encountered air pockets will be aspirated to ensure optimal WE maneuvers in salvage cleaning.
| Study group | Role | What they receive |
|---|---|---|
| CO2 insufflation colonoscopy with an abdominal compression device | Experimental | Colonoscopic insertion will be performed with CO2 insufflation with assistance by an abdominal compression device. Receives: Device: CO2 insufflation with an abdominal compression device |
| CO2 insufflation colonoscopy with a sham abdominal compression device | Sham comparator | Colonoscopic insertion will be performed with CO2 insufflation in standard method. A sham abdominal compression device will be used as a sham comparator. Receives: Device: CO2 insufflation with a sham abdominal compression device |
| Water exchange colonoscopy | Active comparator | Colonoscopic insertion will be performed with water exchange method. Receives: Device: Water exchange colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of manual pressure
The proportion of patients who need at least one application of manual abdominal pressure during colonoscopic insertion.
Measured: One day
Secondary outcomes (7)
Frequency of repositioning
The proportion of patients who need at least one application of position change during colonoscopic insertion.
Measured: One day
Ergonomic pain of after colonoscopy
The musculoskeletal pain experienced by the assisting nurse will be reported based on a 5-point visual analogue scale score immediately after a procedure by using a questionnaire.
Measured: One day
Colonoscopy difficulty
The colonoscopy difficulty assessed by the endoscopist will be reported using a 5-point visual analogue scale score immediately after completion of the procedure by using a questionnaire.
Measured: One day
Post-colonoscopy abdominal pain
The pain experienced by the patient will be recorded in the recovery room post-procedure via a questionnaire using a 5-point visual analogue scale score.
Measured: One day
Cecal intubation time
The cecal intubation time is defined as the time spanning from anal insertion to colonoscopic intubation of cecum.
Measured: One day
Withdrawal time
The withdrawal time is defined as the time spanning from cecal intubation to colonoscope withdrawal from the anus.
Measured: One day
Adenoma detection rate
The proportion of patients with at least one conventional adenoma of any size.
Measured: One week (after the colonoscopy procedure, when pathology report is released)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start2 Sep 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Manual PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evergreen General Hospital, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- E-Da Dachange Hospital, Kaohsiung, Taiwan, The Sepulveda Ambulatory Care Center, VAGLAHS, UCLA in the USA
- Responsible party
- Sponsor
- Investigators
- Chi-Liang Cheng, Principal investigator, Evergreen General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496958
- Sponsor's protocol ID
- EGH-2024
- Status last verified
- Sep 2026
- First submitted
- 20 Jun 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Crockett SD, Cirri HO, Kelapure R, Galanko JA, Martin CF, Dellon ES. Use of an Abdominal Compression Device in Colonoscopy: A Randomized, Sham-Controlled Trial. Clin Gastroenterol Hepatol. 2016 Jun;14(6):850-857.e3. doi: 10.1016/j.cgh.2015.12.039. Epub 2016 Jan 6.
PubMed 26767313Toyoshima O, Nishizawa T, Sakitani K, Yamakawa T, Yoshida S, Fukagawa K, Hata K, Ishihara S, Suzuki H. Colonoscopy using back brace support belt: A randomized, prospective trial. JGH Open. 2019 Nov 7;4(3):441-445. doi: 10.1002/jgh3.12276. eCollection 2020 Jun.
PubMed 32514451Costello B, James T, Hall C, Shergill A, Schlossberg N. Does Manual Abdominal Pressure During Colonoscopy Put Endoscopy Staff and Patients at Risk? Experiences of Endoscopy Nurses and Technicians. Gastroenterol Nurs. 2023 Sep-Oct 01;46(5):386-392. doi: 10.1097/SGA.0000000000000756. Epub 2023 Jun 8.
PubMed 37289853Crockett S, Dellon ES, Biggers L, Ernst DA. Use of Patient Abdominal Compression Device Reduces Staff Musculoskeletal Pain Associated With Supporting Colonoscopy: Results From a Randomized Controlled Trial. Gastroenterol Nurs. 2021 Mar-Apr 01;44(2):136-145. doi: 10.1097/SGA.0000000000000550.
PubMed 33795622Cadoni S, Falt P, Gallittu P, Liggi M, Mura D, Smajstrla V, Erriu M, Leung FW. Water Exchange Is the Least Painful Colonoscope Insertion Technique and Increases Completion of Unsedated Colonoscopy. Clin Gastroenterol Hepatol. 2015 Nov;13(11):1972-80.e1-3. doi: 10.1016/j.cgh.2015.04.178. Epub 2015 May 5.
PubMed 25956838Hsieh YH, Tseng CW, Hu CT, Koo M, Leung FW. Prospective multicenter randomized controlled trial comparing adenoma detection rate in colonoscopy using water exchange, water immersion, and air insufflation. Gastrointest Endosc. 2017 Jul;86(1):192-201. doi: 10.1016/j.gie.2016.12.005. Epub 2016 Dec 15.
PubMed 27988288
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CO2 Insufflation Colonoscopy With an Abdominal Compression Device and Water Exchange Colonoscopy to Reduce Manual Assistance by Endoscopy Staff: A Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT06496958
- Acronym / sponsor ID
- EGH-2024
- Conditions
- Manual Pressure, Repositioning, Colonoscopy, Colon Polyp
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Evergreen General Hospital, TaiwanUniversity, hospital or other
- Collaborators
- E-Da Dachange Hospital, Kaohsiung, Taiwan, The Sepulveda Ambulatory Care Center, VAGLAHS, UCLA in the USA
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this trial is to evaluate whether water exchange colonoscopy and CO2-insufflation colonoscopy with an abdominal compression device (Maxbelt me3 type, Nippon Sigmax Co., Tokyo, Japan) can achieve a significantly lower proportion of patients requiring manual abdominal pressure during colonoscopic insertion compared with CO2 insufflation alone.
Detailed description
This will be a three-arm multicenter parallel randomized controlled trial (RCT) designed to compare the frequency of ancillary manual assistance (abdominal pressure and/or position change) between CO2-insufflation colonoscopy with Maxbelt (intervention group), CO2-insufflation colonoscopy with sham device (sham control group), and water exchange (WE) colonoscopy (WE group). Enrolled patients will be randomized in a 1:1:1 ratio to either the intervention, sham control, or WE group. This will be a comparison of three different methods (CO2 with interventional device, CO2 with sham device, WE) to see which one is better at decreasing the need for manual assistance by endoscopy staff during colonoscopic insertion.
This study will be conducted in two hospitals in Taiwan: Evergreen General Hospital at Taoyuan and E-Da Dachange Hospital at Kaohsiung. The Sepulveda Ambulatory Care Center, VAGLAHS, UCLA in the USA will be a non-recruiting participating site. This planned RCT will span 30 months (from June 2024 to November 2026), including 3 months for the initial setup and 3 months for the final analysis. The study site possesses state-of-the-art colonoscopy equipment setups, and the investigators are WE colonoscopy research experts.
Patients aged 45-75 y/o at average risk of colorectal cancer who are willing to participate will sign an informed consent before starting the colonoscopy procedure. Separate parallel randomization will be set up at each site, stratified by investigator and type of colonoscopy (screening, surveillance, or positive fecal immunochemical test result). Mode of sedation will include conscious sedation (fentanyl plus midazolam) or full sedation (propofol with fentanyl plus midazolam) . Randomization will be carried out by computer-generated sequences using a block design (four participants per block).
CO2 with interventional device group: The Maxbelt will be applied around the circumference of the lower abdomen just below the umbilicus based on patient's abdominal circumference. Five sizes of Maxbelt will be employed in this study: XS-size for 55-65 cm circumference, S-size for 65-75 cm circumference, M-size for 75-85 cm circumference, L-size for 85-95 cm circumference, and XL-size for 95-105 cm circumference. Once applied, participants will be asked to assess and confirm that the belt is fastened tightly but not uncomfortably.
CO2 with sham device group: A two-size larger Maxbelt with loose fitting will be used as a sham device: L-size will be used for 55-71 cm circumference, XL-size will be used for 72-88 cm circumference, and 2 XL-size will be used for 89-105 cm circumference.
WE group: The air pump will be turned off during the insertion phase of colonoscopy, while the colon is irrigated with warm-to-touch distilled water or half normal saline using a flushing pump. The WE approach involves the simultaneous infusion of water to facilitate luminal expansion and suction of unclean water during insertion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CO2 insufflation colonoscopy with an abdominal compression device | Experimental | Device: CO2 insufflation with an abdominal compression deviceColonoscopic insertion will be performed with CO2 insufflation with assistance by an abdominal compression device. |
| CO2 insufflation colonoscopy with a sham abdominal compression device | Sham comparator | Device: CO2 insufflation with a sham abdominal compression deviceColonoscopic insertion will be performed with CO2 insufflation in standard method. A sham abdominal compression device will be used as a sham comparator. |
| Water exchange colonoscopy | Active comparator | Device: Water exchange colonoscopyColonoscopic insertion will be performed with water exchange method. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 45-80 years having an average risk for colorectal cancer who plan to undergo sedated outpatient colonoscopy for screening, surveillance, and those who have received a positive fecal immunochemical test result
Key exclusion criteria (17 listed)
- Patients with hereditary colorectal cancer syndrome, including familial adenomatous polyposis and hereditary nonpolyposis colorectal cancer (Lynch syndrome)
- Patients with serrated polyposis syndrome
- Patients with known or suspected inflammatory bowel disease
- Patients with a history of colorectal cancer or other intra-abdominal malignancy
- Patients with a history of colorectal resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO2 insufflation with an abdominal compression deviceFor participants randomized to the intervention group, the back brace support belt, Maxbelt (me3 type, Nippon Sigmax Co., Tokyo, Japan), will be applied around the circumference of the lower abdomen. Five sizes of Maxbelt will be employed in this study. According to the manufacturer, the ultra small-size (XS-size) belt will be used in those patients with an abdominal circumference of 55 cm-65 cm, the small-size (S-size) belt will be used in those patients with an abdominal circumference of 65 cm-75 cm, the medium-size (M-size) belt will be used for a circumference of 75 cm-85 cm, the large-size (L-size) belt will be used for a circumference of 85 cm-95 cm, and the ultra large-size (XL-size) will be used for a circumference of 95 cm-105 cm. Once applied, participants will be asked to assess and confirm that the belt is fastened tightly but not uncomfortably. | Device | CO2 insufflation colonoscopy with an abdominal compression device |
| CO2 insufflation with a sham abdominal compression deviceThe study coordinator will fit the sham device in a private bay alone with the patient. For participants randomized to the sham control group, a larger-sized Maxbelt with loose fitting will be used as a sham device. The L-size Maxbelt will be used in those patients with an abdominal circumference of 55 cm-71 cm, the XL-size Maxbelt will be used in in those patients with an abdominal circumference of 72 cm-88 cm, and the 2 XL-size Maxbelt will be used in in those patients with abdominal circumference 89 cm-105 cm. | Device | CO2 insufflation colonoscopy with a sham abdominal compression device |
| Water exchange colonoscopyIn those patients assigned to the water exchange (WE) group, the air pump will be turned off during the insertion phase of colonoscopy, while the colon is irrigated with warm-to-touch distilled water or half normal saline using a flushing pump. The WE approach involves the simultaneous infusion of water to facilitate luminal expansion and suction of unclean water during insertion. Any encountered air pockets will be aspirated to ensure optimal WE maneuvers in salvage cleaning. | Device | Water exchange colonoscopy |
Primary outcome
Frequency of manual pressure
Time frame: One day
The proportion of patients who need at least one application of manual abdominal pressure during colonoscopic insertion.
7 secondary outcomes
Frequency of repositioning
Time frame: One day
Ergonomic pain of after colonoscopy
Time frame: One day
Colonoscopy difficulty
Time frame: One day
Post-colonoscopy abdominal pain
Time frame: One day
Cecal intubation time
Time frame: One day
Withdrawal time
Time frame: One day
Adenoma detection rate
Time frame: One week (after the colonoscopy procedure, when pathology report is released)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Results publication: PubMed 26767313Crockett SD, Cirri HO, Kelapure R, Galanko JA, Martin CF, Dellon ES. Use of an Abdominal Compression Device in Colonoscopy: A Randomized, Sham-Controlled Trial. Clin Gastroenterol Hepatol. 2016 Jun;14(6):850-857.e3. doi: 10.1016/j.cgh.2015.12.039. Epub 2016 Jan 6.
- Results publication: PubMed 32514451Toyoshima O, Nishizawa T, Sakitani K, Yamakawa T, Yoshida S, Fukagawa K, Hata K, Ishihara S, Suzuki H. Colonoscopy using back brace support belt: A randomized, prospective trial. JGH Open. 2019 Nov 7;4(3):441-445. doi: 10.1002/jgh3.12276. eCollection 2020 Jun.
- Results publication: PubMed 37289853Costello B, James T, Hall C, Shergill A, Schlossberg N. Does Manual Abdominal Pressure During Colonoscopy Put Endoscopy Staff and Patients at Risk? Experiences of Endoscopy Nurses and Technicians. Gastroenterol Nurs. 2023 Sep-Oct 01;46(5):386-392. doi: 10.1097/SGA.0000000000000756. Epub 2023 Jun 8.
- Results publication: PubMed 33795622Crockett S, Dellon ES, Biggers L, Ernst DA. Use of Patient Abdominal Compression Device Reduces Staff Musculoskeletal Pain Associated With Supporting Colonoscopy: Results From a Randomized Controlled Trial. Gastroenterol Nurs. 2021 Mar-Apr 01;44(2):136-145. doi: 10.1097/SGA.0000000000000550.
- Results publication: PubMed 25956838Cadoni S, Falt P, Gallittu P, Liggi M, Mura D, Smajstrla V, Erriu M, Leung FW. Water Exchange Is the Least Painful Colonoscope Insertion Technique and Increases Completion of Unsedated Colonoscopy. Clin Gastroenterol Hepatol. 2015 Nov;13(11):1972-80.e1-3. doi: 10.1016/j.cgh.2015.04.178. Epub 2015 May 5.
- Results publication: PubMed 27988288Hsieh YH, Tseng CW, Hu CT, Koo M, Leung FW. Prospective multicenter randomized controlled trial comparing adenoma detection rate in colonoscopy using water exchange, water immersion, and air insufflation. Gastrointest Endosc. 2017 Jul;86(1):192-201. doi: 10.1016/j.gie.2016.12.005. Epub 2016 Dec 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jen-Hao Yeh, MD contact
Chi-Liang Cheng principal investigator
Evergreen General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO2 insufflation with an abdominal compression device and Water exchange colonoscopy in people with Manual Pressure and Repositioning, run by Evergreen General Hospital, Taiwan at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chi-Liang Cheng, MD (+886-919768058, chiliang.cheng@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of manual pressure (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06496958, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.